# Osseofuse International, Inc.

- Location (FDA's records): Calabasas, CA
- FDA decisions: 2 (2019–2025): 2 510(k) clearances
- Product codes: DZE (2)
- Predicates its devices cite: 1 (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

## Its most-cited devices
- K181157: Conical Plus Implant System (2019), cited by 1

## Recent decisions
- K243078: HexaPLUS S OneDrill Implant System (Oct 10, 2025)
- K181157: Conical Plus Implant System (May 24, 2019)

Source page: https://510kreport.com/company/osseofuse-international