SMG Anterior Cervical Plate System
FDA 510(k) K183073 · Sapphire Medical Group
510(k) numberK183073
Submission
- Device name
- SMG Anterior Cervical Plate System
- Applicant
- Sapphire Medical Group
Dana Point, CA, US - Received
- November 5, 2018
- Decision date
- February 11, 2019
- 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 |
|---|---|---|
| K232619 | MATRIX HA PEEK Cervical IBF SystemODP · Special | 03/19/2024SE |
| K192316 | Matrix HA PEEK Cervical Implant SystemODP · Special | 10/17/2019SE |
| K172674 | Sapphire Cervical Implant SystemODP · Special | 11/02/2017SE |
| K121693 | A-Wedge Anterior Interbody System (A-Wedge Ais)MAX · Traditional | 12/27/2012SE |
Questions and answers
When was SMG Anterior Cervical Plate System cleared by the FDA?
SMG Anterior Cervical Plate System (K183073) received a 510(k) decision of Substantially Equivalent on February 11, 2019, 98 days after the submission was received.
What is the product code of K183073?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.