Modification to: Lanx Anterior Cervical Plate System
FDA 510(k) K090316 · Lanx, Inc.
510(k) numberK090316
Submission
- Device name
- Modification to: Lanx Anterior Cervical Plate System
- Applicant
- Lanx, Inc.
Broomfield, CO, US - Received
- February 9, 2009
- Decision date
- April 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K131547 | Lanx Fusion SystemOVD · Special | 07/12/2013SE |
| K131156 | Lanx Spinal Fixation SystemKWP · Special | 05/24/2013SE |
| K123767 | Lanx Fusion System- SAOVD · Traditional | 03/18/2013SE |
| K121316 | Lanx Spinal Fization SystemNKB · Traditional | 09/10/2012SE |
| K122145 | Lanx Spinal Fixation SystemNKB · Special | 08/17/2012SE |
| K121940 | Lanx Spinal Fixation SystemNKB · Special | 08/02/2012SE |
| K120399 | Lanx Spinal Fixation SystemNKB · Special | 03/09/2012SE |
| K113434 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)NKB · Special | 12/19/2011SE |
| K112388 | Lanx Cervical SAOVE · Traditional | 12/16/2011SE |
| K103091 | Lanx Spinal Fixation SystemKWP · Special | 04/15/2011SE |
Questions and answers
When was Modification to: Lanx Anterior Cervical Plate System cleared by the FDA?
Modification to: Lanx Anterior Cervical Plate System (K090316) received a 510(k) decision of Substantially Equivalent on April 7, 2009, 57 days after the submission was received.
What is the product code of K090316?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.