# Elevation Spine

- Location (FDA's records): Monteray, CA
- FDA decisions: 5 (2019–2026): 5 510(k) clearances
- Product codes: OVE (4), OVD (1)
- 510(k) review time since 2016: median 95 days, against 87 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 7 (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
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- Lincotek Medical: 1 (https://510kreport.com/company/lincotek-medical)
- Zavation Medical Products, LLC: 1 (https://510kreport.com/company/zavation-medical-products)
- NanoHive Medical, LLC: 1 (https://510kreport.com/company/nanohive-medical)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)

## Its most-cited devices
- K190885: Elevation Spine Saber-C System (2019), cited by 5
- K250540: SABER-C System (2025), cited by 1
- K260660: SABER-C System (2026), cited by 1

## Recent decisions
- K263049: SABER-C System (Sep 23, 2026)
- K261408: SABER-XA System (Aug 3, 2026)
- K260660: SABER-C System (Apr 27, 2026)
- K250540: SABER-C System (Aug 8, 2025)
- K190885: Elevation Spine Saber-C System (Aug 7, 2019)

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