Panels › Orthopedic › Product code OVD · Class 2
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation 888.3080
9510(k)s in 12 months (205 all time)
2recalls in 12 months (36 all time)
36recalls that name a 510(k)
Top companies in OVD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2026 | Novapproach Spine, LLC OneLIF Interbody Cage (REF/Description):
010-107-1007/Small 7 Degree 10mm X 7mm,
010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique,
010-107-1209/Small 7 Degree 12mm X 9mm,
010-107-1411/Small 7 Degree Open, Classified |
OVD | K211769 |
| Dec 11, 2025 | Orthofix U.S. LLC Brand Name: Pillar" SA PTC Spacer System
Product Name: Pillar" SA PTC Spacer System
Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT;
39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT;
39 Open, Classified |
OVD | K172437 |
| Sep 11, 2025 | Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. Open, Classified |
OVD | K203207 |
| Sep 11, 2025 | Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree. Open, Classified |
OVD | K203207 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 22mm; Catalog 48019140. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Open, Classified |
OVD | K201585 |
| Mar 31, 2025 | Stryker Spine Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Open, Classified |
OVD | K201585 |
| Feb 19, 2025 | XTANT Medical Holdings, Inc Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE)) Open, Classified |
OVD | K171567 |
| 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 24, 2023 | Medicrea International IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar Open, Classified |
OVD | K141187 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant Open, Classified |
OVD | K212653 |
| Jul 10, 2023 | Medtronic Sofamor Danek USA Inc Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant Open, Classified |
OVD | K212653 |
| Apr 24, 2023 | SPINEART SA JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S;
JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 0 Open, Classified |
OVD | K190877 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device Completed |
OVD | K221545 |
| Apr 19, 2023 | Medacta Usa Inc MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device Completed |
OVD | K221545 |
| Nov 17, 2022 | Novapproach Spine LLC OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS. Terminated |
OVD | K211769 |
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm Terminated |
OVD | K141953 K173535 +2 |
| Jan 7, 2019 | Acuity Surgical Devices, LLC A LINK Z INTERVERTEBRAL BODY FUSION DEVICE
Product Description:
A Link Z Ti Unitary Open Interbody 32x24x12 7
A Link Z Ti Unitary Open Interbody 32x24x12 12
A Link Z Ti Unitary Open Interbody 32x24x1 Open, Classified |
OVD | K133827 |
| Jan 7, 2019 | Acuity Surgical Devices, LLC A LINK Z INTERVERTEBRAL BODY FUSION DEVICE
Product Description:
A Link Z Ti Unitary Plate-Cage 32x21x15 7
A Link Z Ti Unitary Plate-Cage 32x21x15 12
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Open, Classified |
OVD | K133827 |
| Apr 9, 2018 | VGI Medical, LLC VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit Terminated |
OVD | K151312 |
| Dec 22, 2016 | Amendia, Inc Optimus Fixed Awl Terminated |
OVD | K132596 |
| Feb 12, 2016 | Biomet Spine, LLC 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
Product Usage:
The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for s Terminated |
OVD | K081501 |
| Jan 15, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into t Terminated |
OVD | K123767 |
| Jan 15, 2015 | Biomet Spine, LLC Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.
Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into Terminated |
OVD | K123767 |
| Jan 14, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204
Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF Terminated |
OVD | K123767 |
| Nov 26, 2013 | Lanx, Inc. LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107.
The Timberline MPF device is an intervertebral body fusion device consi Terminated |
OVD | K123767 K131547 |
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