G Surgical OCT Spinal System
FDA 510(k) K171834 · G Surgical, LLC
510(k) numberK171834
Submission
- Device name
- G Surgical OCT Spinal System
- Applicant
- G Surgical, LLC
Austin, TX, US - Received
- June 20, 2017
- Decision date
- December 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following…
Other 510(k)s with product code NKG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/02/2026SE |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 01/21/2026SE |
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | Icotec AG | 11/12/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
More from MiRus, LLC
| 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 |
| K161516 | G Surgical Marksman MIS SystemNKB · Traditional | 08/25/2016SE |
| K142456 | GPS SpacersODP · Traditional | 04/10/2015SE |
| K103070 | GPS TM, G Surgical Anterior Cervical Plate System +KWQ · Traditional | 01/12/2011SE |
| K081041 | GPS, G Surgical Pedicle SystemMNH · Traditional | 06/27/2008SE |
Questions and answers
When was G Surgical OCT Spinal System cleared by the FDA?
G Surgical OCT Spinal System (K171834) received a 510(k) decision of Substantially Equivalent on December 19, 2017, 182 days after the submission was received.
What is the product code of K171834?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.