# Novapproach Spine

- Location (FDA's records): Alachua, FL
- FDA decisions: 2 (2021–2025): 2 510(k) clearances
- Names in FDA's records: Novapproach Spine (1); Novapproach Spine, LLC (1)
- Product codes: OVD (2)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Acuity Surgical Devices, LLC: 1 (https://510kreport.com/company/acuity-surgical-devices)

## Its most-cited devices
- K211769: OneLIF Intervertebral Body Replacement System (2021), cited by 1

## Recent decisions
- K251459: OneLIF™ Interbody Fusion System (Jun 12, 2025)
- K211769: OneLIF Intervertebral Body Replacement System (Sep 7, 2021)

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