inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
FDA 510(k) K143626 · Zimmer Spine, Inc.
510(k) numberK143626
Submission
- Device name
- inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- December 22, 2014
- Decision date
- March 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation SystemNKG · Special | 02/16/2016SE |
| K150896 | Vitality Spinal Fixation SystemNKB · Traditional | 08/31/2015SE |
| K151031 | Virage OCT Spinal Fixation SystemNKG · Traditional | 06/24/2015SE |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…NKB · Traditional | 06/18/2015SE |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…MAX · Traditional | 02/12/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K141500 | Optio-C Anterior Cervical SystemKWQ · Traditional | 09/23/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | 06/02/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
| K133184 | Ardis Interbody SystemMAX · Traditional | 01/30/2014SE |
Questions and answers
When was inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System cleared by the FDA?
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System (K143626) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 88 days after the submission was received.
What is the product code of K143626?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.