# Orthofab, Inc.

- Location (FDA's records): Quebec, Quebec, CA
- FDA decisions: 7 (1985–1997): 7 510(k) clearances
- Product codes: ITI (3), IOR (2), KCY (1), GES (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K962565: Powered Wheelchair (Mar 20, 1997)
- K952675: Orthofab Wheelchair (May 7, 1996)
- K950904: Orthofab Wheelchair Astra (Folding Manual Wheelchair) (Apr 5, 1995)
- K950903: Orthofab Wheelchair Ultima (Rigid Frame Manual Wheelchair) (Apr 5, 1995)
- K884812: Karma-RS, Karma-FS Wheelchairs (Dec 27, 1988)
- K860095: Digikit  Nonpneumatic Tourniquet (Jan 24, 1986)
- K852661: Apollo Sterile Blades (Jul 11, 1985)

Source page: https://510kreport.com/company/orthofab