# Synovis Orthopedic & Woundcare

- Location (FDA's records): Irvine, CA
- FDA decisions: 3 (2011–2012): 3 510(k) clearances
- Product codes: HWC (1), KGN (1), FTM (1)
- Predicates its devices cite: 15 (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
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Pegasus Biologics, Inc.: 3 (https://510kreport.com/company/pegasus-biologics)
- Synovis Surgical Innovations: 2 (https://510kreport.com/company/synovis-surgical-innovations)
- Cryolife, Inc.: 2 (https://510kreport.com/company/cryolife)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew Inc., Endoscopy Div.: 1 (https://510kreport.com/company/smith-nephew-endoscopy-div)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)
- Organogenesis, Inc.: 1 (https://510kreport.com/company/organogenesis)

## Recent decisions
- K113460: Synergy Tissue Matrix (Jan 11, 2012)
- K112399: Unite Biomatrix (Sep 7, 2011)
- K110538: Pro Fixation System (Jul 12, 2011)

Source page: https://510kreport.com/company/synovis-orthopedic-woundcare