Manta Ray Anterior Cervical Plate System
FDA 510(k) K080690 · Theken Spine, LLC
510(k) numberK080690
Submission
- Device name
- Manta Ray Anterior Cervical Plate System
- Applicant
- Theken Spine, LLC
Akron, OH, US - Received
- March 11, 2008
- Decision date
- April 25, 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 |
|---|---|---|
| K121482 | Instrument System for Endoscopic Spinal SurgeryHRX · Traditional | 08/28/2012SE |
| K121211 | Vu Apod Intervertebral Body Fusion DeviceOVD · Special | 06/27/2012SE |
| K120829 | Stainless Steel Spinal SystemNKB · Special | 05/30/2012SE |
| K120047 | Coral Spinal SystemNKB · Special | 02/03/2012SE |
| K111675 | Vu C*Pod Intervertebral Body Fusion DeviceODP · Special | 08/02/2011SE |
| K103228 | Paramount R Ibf DeviceMAX · Special | 01/05/2011SE |
| K102323 | Cervical Standalone Intervertebral Body Fusion DeviceOVE · Traditional | 12/16/2010SE |
| K101310 | Vu Apod Intervertebral Body Fusion DeviceOVD · Traditional | 09/02/2010SE |
| K100970 | Stainless Steel Spinal SystemNKB · Traditional | 08/12/2010SE |
| K091266 | Theken Coral Spinal SystemNKB · Special | 06/10/2009SE |
Questions and answers
When was Manta Ray Anterior Cervical Plate System cleared by the FDA?
Manta Ray Anterior Cervical Plate System (K080690) received a 510(k) decision of Substantially Equivalent on April 25, 2008, 45 days after the submission was received.
What is the product code of K080690?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.