Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | K183060 |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative dis Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Jan 15, 2021 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative di Open, Classified |
KWQ | None listed |
| Apr 7, 2020 | Innovasis, Inc Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation. Terminated |
KWQ | K192049 |
| Feb 22, 2019 | Zimmer Biomet Spine Inc. Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use Terminated |
KWQ | K150896 |
| Mar 23, 2018 | Medtronic Sofamor Danek USA Inc Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm
Product Appliance, fixation, spinal intervertebral body Terminated |
KWQ | K141632 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizati Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | K153042 |
| Nov 13, 2017 | Amendia, Inc dba Spinal Elements Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System
The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Terminated |
KWQ | K092531 |
| May 23, 2017 | Innovasis, Inc Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag.
Product Usage:
4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. T Terminated |
KWQ | K061147 |
| Apr 26, 2017 | Ulrich Medical USA Inc uNion Cervical Plate System
Product Usage:
The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the Terminated |
KWQ | K150666 |
| Dec 22, 2016 | Amendia, Inc Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030
The Black Widow Buttress Plates and Screws ar Terminated |
KWQ | K081770 |
| Dec 22, 2016 | Amendia, Inc Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123
The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of all Terminated |
KWQ | K081770 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm
Item Code: 186864018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm
Item Code: 186862018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm
Item Code: 186854018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 fo Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm
Item Code: 186852026
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm
Item Code: 186852020
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186852018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186850018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Apr 20, 2016 | Synthes (USA) Products LLC Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879 Terminated |
KWQ | K000536 K971883 |
| Dec 21, 2015 | DePuy Spine, Inc. Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. Terminated |
KWQ | None listed |
| Nov 3, 2015 | Biomet Spine, LLC MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. Terminated |
KWQ | K080646 K133518 |
| Sep 9, 2015 | Biomet Spine, LLC Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. Terminated |
KWQ | K080646 |
| Jul 14, 2015 | Exactech, Inc. Exactech Single Barrel Drill Guides
The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surge Terminated |
KWQ | K143576 |
| Jul 14, 2015 | Exactech, Inc. Exactech Ambassador Cervical Plate System
The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined Terminated |
KWQ | K142576 |
| Jul 7, 2015 | Alliance Partners LLC Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide
Product Usage:
The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at Terminated |
KWQ | K141993 |
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