# Republic Spine, LLC

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 7 (2015–2023): 7 510(k) clearances
- Product codes: NKB (3), ODP (1), MAX (1), MNH (1), OLO (1)
- 510(k) review time since 2016: median 148 days, against 82 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 14 (3 its own); citations of its devices by later devices: 4 (3 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
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)
- Choicespine, LP: 2 (https://510kreport.com/company/choicespine)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Zavation Medical Products, LLC: 1 (https://510kreport.com/company/zavation-medical-products)
- OrthoPediatrics Corp.: 1 (https://510kreport.com/company/orthopediatrics)
- Silony Medical GmbH: 1 (https://510kreport.com/company/silony-medical)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Osteomed Indústria E Comércio DE Implantes Ltda: 1 (https://510kreport.com/company/osteomed-industria-e-comercio-de-implantes)

## Its most-cited devices
- K181495: Republic Spine Dark Star Spinal System (2018), cited by 1
- K150283: Republic Spine Dark Star Spinal System (2015), cited by 1
- K201420: Republic Spine Dark Star Spinal System (2021), cited by 1
- K223096: Dark Star Deformity Pedicle Screw System (2023), cited by 1

## Recent decisions
- K223096: Dark Star Deformity Pedicle Screw System (May 26, 2023)
- K212028: Dark Star Navigation Instrument System (Sep 27, 2021)
- K201420: Republic Spine Dark Star Spinal System (Mar 5, 2021)
- K190398: Republic Spine Restore Intervertebral Body Fusion System (Sep 12, 2019)
- K190889: Republic Spine Restore Cervical Interbody Fusion System (Jun 19, 2019)
- K181495: Republic Spine Dark Star Spinal System (Jul 25, 2018)
- K150283: Republic Spine Dark Star Spinal System (Apr 29, 2015)

Source page: https://510kreport.com/company/republic-spine