Medina Anterior Cervical Plate System
FDA 510(k) K201521 · Alliance Partners, LLC
510(k) numberK201521
Submission
- Device name
- Medina Anterior Cervical Plate System
- Applicant
- Alliance Partners, LLC
San Antonio, TX, US - Received
- June 8, 2020
- Decision date
- August 6, 2020
- 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 |
|---|---|---|
| K173128 | Alamo® CODP · Traditional | 03/22/2018SE |
| K141123 | Alliance Spine Raas Cranial Plating SystemGWO · Traditional | 02/27/2015SE |
| K141993 | Nakoma AcpKWQ · Traditional | 11/06/2014SE |
| K140303 | Alamo TMAX · Special | 04/21/2014SE |
| K133321 | Alamo CODP · Special | 01/09/2014SE |
| K120401 | Alamo TMAX · Traditional | 10/05/2012SE |
| K122047 | Alamo PMAX · Traditional | 09/04/2012SE |
| K121181 | Swannshidi Bone Marrow Aspiration NeedleKNW · Traditional | 08/22/2012SE |
| K112361 | Alamo CODP · Traditional | 11/30/2011SE |
Questions and answers
When was Medina Anterior Cervical Plate System cleared by the FDA?
Medina Anterior Cervical Plate System (K201521) received a 510(k) decision of Substantially Equivalent on August 6, 2020, 59 days after the submission was received.
What is the product code of K201521?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.