# G Surgical, LLC

- Location (FDA's records): Austin, TX
- FDA decisions: 9 (2008–2024): 9 510(k) clearances
- Names in FDA's records: G Surgical, LLC (7); G Surgical Co., Ltd. (2)
- Product codes: NKB (4), ODP (2), KWQ (1), MNH (1), NKG (1)
- 510(k) review time since 2016: median 30 days, against 84 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 22 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- U&I Corporation: 2 (https://510kreport.com/company/u-i)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Medicrea Technologies: 1 (https://510kreport.com/company/medicrea-technologies)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)

## Its most-cited devices
- K161516: G Surgical Marksman MIS System (2016), cited by 3
- K081041: GPS, G Surgical Pedicle System (2008), cited by 2
- K193219: G Surgical Marksman System (2019), cited by 1
- K142456: GPS Spacers (2015), cited by 1

## Recent decisions
- K240737: G Surgical Marksman MIS System (Apr 5, 2024)
- K230063: G Surgical Marksman Spinal Deformity System (Feb 9, 2023)
- K210890: GPS Cervical Spacers (Apr 23, 2021)
- K193219: G Surgical Marksman System (Dec 17, 2019)
- K171834: G Surgical OCT Spinal System (Dec 19, 2017)
- K161516: G Surgical Marksman MIS System (Aug 25, 2016)
- K142456: GPS Spacers (Apr 10, 2015)
- K103070: GPS TM, G Surgical Anterior Cervical Plate System + (Jan 12, 2011)

Source page: https://510kreport.com/company/g-surgical