# Flospine

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 5 (2014–2023): 5 510(k) clearances
- Names in FDA's records: Flospine (4); Flospine, LLC (1)
- Product codes: KWQ (1), PEK (1), ODP (1), NKB (1), MAX (1)
- 510(k) review time since 2016: median 79 days, against 83 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 1 (1 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
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Centerpulse Spine-Tech, Inc.: 1 (https://510kreport.com/company/centerpulse-spine-tech)
- Paradigm Spine, LLC: 1 (https://510kreport.com/company/paradigm-spine)
- X-Spine Systems, Inc.: 1 (https://510kreport.com/company/x-spine-systems)
- Additive Implants, Inc.: 1 (https://510kreport.com/company/additive-implants)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- U&I Corp., America: 1 (https://510kreport.com/company/u-i-america)
- Tides Medical: 1 (https://510kreport.com/company/tides-medical)

## Its most-cited devices
- K193255: Largo PEEK Interbody System (2020), cited by 1

## Recent decisions
- K232484: KeyLift™ Expandable Interlaminar Stabilization System (Oct 19, 2023)
- K223231: Ti-Largo Cervical Interbody System (Feb 24, 2023)
- K210182: PANAMA™ Anterior Cervical Plate (ACP) System (Apr 7, 2021)
- K193255: Largo PEEK Interbody System (Feb 20, 2020)
- K141850: Flospine Pedicle Screw System (Oct 27, 2014)

Source page: https://510kreport.com/company/flospine