# Empirical Spine, Inc.

- Location (FDA's records): Morgan Hill
- FDA decisions: 2 (2026–2026): 1 510(k) clearance and 1 original PMA approval
- Names in FDA's records: Empirical Spine, Inc. (1); Empirical Spine (1)
- Product codes: SGK (1), SGL (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 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
- Companion Spine France: 1 (https://510kreport.com/company/companion-spine-france)

## Recent decisions
- K253374: LimiFlex® Dynamic Sagittal Tether Instrument Set (Jun 16, 2026)
- P220031: LimiFlex Dynamic Sagittal Tether (Feb 12, 2026)

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