Company · US
Alphatec Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
102510(k) clearances (6 in 12 months)
57recalls (3 in 12 months)
52recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 41 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 25 |
| NKB | Thoracolumbosacral Pedicle Screw System | 25 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 10 |
| OLO | Orthopedic Stereotaxic Instrument | 10 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 |
| MQP | Spinal Vertebral Body Replacement Device | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 |
| NKG | Posterior Cervical Screw System | 3 |
| PDQ | Neurosurgical Nerve Locator | 3 |
| MRW | System, Facet Screw Spinal Device | 2 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | 2 |
| GAD | Retractor | 1 |
| HWJ | Awl | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| LRP | Tray, Surgical | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K262646 | Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody Syst Alphatec Spine, Inc. | MAX |
| Jul 14, 2026 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Jun 25, 2026 | K253216 | IntraOp Alignment System; CONTOUR3D Bending System Alphatec Spine, Inc. | SIN |
| Mar 25, 2026 | K253615 | Invictus Bands System Alphatec Spine, Inc. | OWI |
| Feb 19, 2026 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) Alphatec Spine, Inc. | OLO |
| Jan 11, 2026 | K252842 | SafeOp 3: Neural Informatix System Alphatec Spine, Inc. | GWF |
| Sep 3, 2025 | K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System Alphatec Spine | OVD |
| Aug 28, 2025 | K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) Alphatec Spine, Inc. | KWQ |
| Jul 3, 2025 | K251080 | IdentiTi II Cervical Interbody System Alphatec Spine, Inc. | ODP |
| Mar 4, 2025 | K243461 | Calibrate Interbody Systems Alphatec Spine, Inc. | |
| Feb 3, 2025 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; Id Alphatec Spine | MAX |
| Oct 4, 2024 | K242364 | IdentiTi II Interbody System Alphatec Spine, Inc. | MAX |
| Sep 20, 2024 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System Alphatec Spine, Inc. | MAX |
| Jun 21, 2024 | K241519 | Invictus® Small Stature Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Jun 6, 2024 | K240951 | Invictus Robotic Navigation Instruments Alphatec Spine | OLO |
| May 22, 2024 | K240199 | IntraOp Alignment System Alphatec Spine, Inc. | OWB |
| Apr 19, 2024 | K234092 | SafeOp 3: Neural Informatix Systeem Alphatec Spine, Inc. | GWF |
| Feb 22, 2024 | K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interb Alphatec Spine, Inc. | KWQ |
| Nov 2, 2023 | K232345 | ATEC Posterior Navigated Disc Prep Instruments Alphatec Spine, Inc. | OLO |
| Oct 13, 2023 | K232504 | Calibrate CCX Interbody System Alphatec Spine, Inc. | MAX |
| Oct 6, 2023 | K232173 | Ascend VBR System, Ascend NanoTec VBR System Alphatec Spine, Inc. | MQP |
| Oct 6, 2023 | K232044 | Invictus Robotic Navigation Instruments Alphatec Spine, Inc. | OLO |
| Sep 27, 2023 | K232275 | Invictus® Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Sep 25, 2023 | K232097 | IdentiTi ALIF Interbody Systems Alphatec Spine, Inc. | OVD |
| Sep 8, 2023 | K232413 | Fusion Robotic Navigation System Alphatec Spine, Inc. | OLO |
| Jul 13, 2023 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System Alphatec Spine, Inc. | MAX |
| May 9, 2023 | K230721 | ATEC Lateral Plate System Alphatec Spine, Inc. | KWQ |
| Mar 29, 2023 | K223611 | Calibrate LTX Interbody System Alphatec Spine, Inc. | MAX |
| Mar 23, 2023 | K223765 | ATEC Lateral Navigation Instruments Alphatec Spine, Inc. | OLO |
| Dec 20, 2022 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System Alphatec Spine, Inc. | PML |
| Nov 18, 2022 | K222455 | Calibrate LTX Interbody System Alphatec Spine, Inc. | MAX |
| Nov 17, 2022 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Inter Alphatec Spine, Inc. | ODP |
| Oct 7, 2022 | K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend Alphatec Spine | MAX |
| Sep 23, 2022 | K221821 | ATEC IOM Accessory Instruments Alphatec Spine, Inc. | PDQ |
| Jun 9, 2022 | K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend Alphatec Spine, Inc. | MAX |
| Apr 4, 2022 | K214006 | Invictus® Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Mar 9, 2022 | K213849 | SafeOp 2: Neural Informatix System Alphatec Spine, Inc. | GWF |
| Dec 15, 2021 | K213443 | Insignia Anterior Cervical Plate System Alphatec Spine, Inc. | KWQ |
| Dec 10, 2021 | K213460 | Invictus Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Oct 29, 2021 | K211987 | ATEC Alignment App Alphatec Spine, Inc. | LLZ |
| Sep 22, 2021 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoT Alphatec Spine, Inc. | MAX |
| Aug 10, 2021 | K211873 | PSX Interbody System Alphatec Spine, Inc. | MAX |
| Apr 9, 2021 | K203742 | IdentiTi ALIF Standalone Interbody System Alphatec Spine, Inc. | OVD |
| Dec 18, 2020 | K203125 | Invictus OCT Spinal Fixation System Alphatec Spine, Inc. | NKG |
| Dec 18, 2020 | K202812 | IdentiTi Cervical Standalone Interbody System Alphatec Spine, Inc. | OVE |
| Nov 23, 2020 | K203056 | Invictus Spinal Fixation System Alphatec Spine, Inc. | NKB |
| Nov 6, 2020 | K202587 | ATEC Lateral Interbody System Alphatec Spine, Inc. | MAX |
| Oct 15, 2020 | K202327 | Invictus OsseoScrew® System Alphatec Spine, Inc. | NKB |
| May 22, 2020 | K200936 | Invictus CT Spinal Fixation System Alphatec Spine, Inc. | NKG |
| May 21, 2020 | K200995 | Insignia Anterior Cervical Plate System Alphatec Spine, Inc. | KWQ |
Newest 50 of 102.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2026 | Alphatec Spine, Inc. SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Open, Classified |
GWF | K252842 |
| Feb 11, 2026 | Alphatec Spine, Inc. ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N
UDI-DI code: 00190376541471; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in sur Open, Classified |
OLO | K223765 |
| Feb 11, 2026 | Alphatec Spine, Inc. ATEC Lateral Navigation Disc Prep Instruments
LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N
UDI-DI code: 00190376476179; GMDN 12844
The ATEC Navigation Disc Prep Instruments are intended for use in sur Open, Classified |
OLO | K223765 |
| Jan 30, 2025 | Alphatec Spine, Inc. Calibrate CCX Interbody System for spinal fusion procedures:
Implants:
(1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile;
(2) Calibrate CCX-O, 7 x 10 x 25mm 10 degree Open, Classified |
MAX | K232504 |
| Feb 23, 2024 | Alphatec Spine, Inc. IdentiTi ALIF Standalone Interbody System:
Part Number/Description
132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm
132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm
132-10-85-350 / I Open, Classified |
OVD | K232097 |
| Aug 28, 2023 | Alphatec Spine, Inc. LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF, Open, Classified |
HWJ | None listed |
| Nov 8, 2022 | Alphatec Spine, Inc. Disc Preparation instruments contained in the following products:
CI-11050-08102515
Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15
TC11050
00840180510810
CI-11050-09102515
Longer IdentiTi PO Open, Classified |
OLO | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439 Terminated |
KWQ | K200995 |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 Terminated |
KWQ | K200995 |
| May 5, 2017 | Alphatec Spine, Inc. Arsenal Spinal Fixation System, Set Screw, Part No. 47027
Product Usage:
The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for t Terminated |
NKB | K133221 |
| Nov 16, 2016 | Alphatec Spine, Inc. Arsenal Spinal Fixation System, Set Screw, Part No. 47127
Product Usage: Usage:
The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for Terminated |
NKB | K133221 |
| Apr 29, 2015 | Alphatec Spine, Inc. 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm
Alphatec Spine
Solutions for the Aging Spine
Trestle Luxe Anterior Cervical Plating System
REF 71240-14
LOT XXXXXX
Alphatec Spine, Inc.
EN: 4 Terminated |
KWQ | K102820 |
| Jul 22, 2014 | Alphatec Spine, Inc. Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thora Terminated |
NKB | K131119 |
| Aug 27, 2013 | Alphatec Spine, Inc. Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary i Terminated |
NKB | K123623 |
| May 28, 2013 | Alphatec Spine, Inc. Leucadia Autolok" Polyaxial Pedicle Screw System.
Intended to help provide correction, immobilization and stabilization of spinal segments. Terminated |
NKB | K113366 |
| Mar 18, 2013 | Alphatec Spine, Inc. ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical co Terminated |
KWP | K042673 |
| Nov 8, 2012 | Alphatec Spine, Inc. TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55.
Subsequent Product Codes: MNH, MNI.
The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation Terminated |
KWP | K033090 |
| Oct 29, 2012 | Alphatec Spine, Inc. ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System,
Orthosis, Spinal Pedical Fixation
Orthosis, Spondylolisthesis Spinal Fixation
The ILLICO MIS Posterior Fixation Sys Terminated |
MNH | K042673 K071890 |
| Aug 27, 2012 | Alphatec Spine, Inc. TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820.
The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bo Terminated |
KWQ | K102820 |
| May 29, 2012 | Alphatec Spine, Inc. SOLUS Anterior Lumbar Interbody Fusion Spinal
Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402.
The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated f Terminated |
MAX | K102402 |
| Jan 31, 2012 | Alphatec Spine, Inc. Solanas Posterior Stabilization System Part Number: 63920.
Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation an Terminated |
KWP | K052201 K071380 |
| Jun 2, 2010 | Alphatec Spine, Inc. Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008.
Intended for the temporary stabilization of the anterior spine during the development of Terminated |
KWQ | K070681 |
| Dec 14, 2009 | Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14 Terminated |
KWP | K052201 K071380 |
Newest 50 of 57.