GPS TM, G Surgical Anterior Cervical Plate System +
FDA 510(k) K103070 · G Surgical Co., Ltd.
510(k) numberK103070
Submission
- Device name
- GPS TM, G Surgical Anterior Cervical Plate System +
- Applicant
- G Surgical Co., Ltd.
Bangkok, TH - Received
- October 18, 2010
- Decision date
- January 12, 2011
- 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 |
|---|---|---|
| K240737 | G Surgical Marksman MIS SystemNKB · Special | 04/05/2024SE |
| K230063 | G Surgical Marksman Spinal Deformity SystemNKB · Special | 02/09/2023SE |
| K210890 | GPS Cervical SpacersODP · Special | 04/23/2021SE |
| K193219 | G Surgical Marksman SystemNKB · Special | 12/17/2019SE |
| K171834 | G Surgical OCT Spinal SystemNKG · Traditional | 12/19/2017SE |
| K161516 | G Surgical Marksman MIS SystemNKB · Traditional | 08/25/2016SE |
| K142456 | GPS SpacersODP · Traditional | 04/10/2015SE |
| K081041 | GPS, G Surgical Pedicle SystemMNH · Traditional | 06/27/2008SE |
Questions and answers
When was GPS TM, G Surgical Anterior Cervical Plate System + cleared by the FDA?
GPS TM, G Surgical Anterior Cervical Plate System + (K103070) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 86 days after the submission was received.
What is the product code of K103070?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.