C-Tek Maxan Anterior Cervical Plate System
FDA 510(k) K080646 · Biomet Spine
510(k) numberK080646
Submission
- Device name
- C-Tek Maxan Anterior Cervical Plate System
- Applicant
- Biomet Spine
Parsippany, NJ, US - Received
- March 6, 2008
- Decision date
- May 2, 2008
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K152622 | Alta ACDF SystemOVE · Traditional | 07/08/2016SE |
| K153695 | Biomet Spine Fusion SystemMAX · Special | 01/21/2016SE |
| K151974 | Polaris Spinal SystemNKB · Traditional | 11/13/2015SE |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…OVE · Traditional | 08/12/2015SE |
| K151483 | Biomet Spine Fusion SystemMAX · Traditional | 07/31/2015SE |
| K151224 | Lineum OCT Spine SystemNKG · Traditional | 06/30/2015SE |
| K142634 | Biomet Spine Fusion SystemMAX · Traditional | 03/12/2015SE |
| K141791 | Biomet Fusion SystemOVD · Traditional | 10/09/2014SE |
| K141804 | Polaris Spinal System - Ha CoatedNKB · Traditional | 09/25/2014SE |
| K121130 | Polaris Spinal System-Ballista Spinal RodsNKB · Special | 06/15/2012SE |
Questions and answers
When was C-Tek Maxan Anterior Cervical Plate System cleared by the FDA?
C-Tek Maxan Anterior Cervical Plate System (K080646) received a 510(k) decision of Substantially Equivalent on May 2, 2008, 57 days after the submission was received.
What is the product code of K080646?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.