# Synovis Surgical Innovations

- Location (FDA's records): St. Paul, MN
- FDA decisions: 9 (1979–2013): 8 510(k) clearances and 1 original PMA approval
- Product codes: FTM (4), DXZ (2), LXA (1), OXE (1), DRB (1)
- Predicates its devices cite: 30 (8 its own); citations of its devices by later devices: 20 (8 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Vascular, Inc.: 10 (https://510kreport.com/company/bio-vascular)
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)
- Genetic Laboratories, Inc.: 2 (https://510kreport.com/company/genetic-laboratories)
- Sofradim Production: 2 (https://510kreport.com/company/sofradim-production)
- Pacesetter, Inc.: 1 (https://510kreport.com/company/pacesetter)
- Genetic: 1 (https://510kreport.com/company/genetic)
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)
- Medical Device Consultants, Inc.: 1 (https://510kreport.com/company/medical-device-consultants)

## Firms that cite its devices most
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Synovis Orthopedic & Woundcare: 2 (https://510kreport.com/company/synovis-orthopedic-woundcare)
- Synovis Life Technologies, Inc. (Baxter International Inc.): 2 (https://510kreport.com/company/synovis-life-technologies-baxter-international)
- Kerecis Limited: 1 (https://510kreport.com/company/kerecis)
- Tyco Healthcare Group LP: 1 (https://510kreport.com/company/tyco-healthcare-group)
- Collafirm, LLC: 1 (https://510kreport.com/company/collafirm)
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)
- Gunze Limited: 1 (https://510kreport.com/company/gunze)

## Its most-cited devices
- K062915: Veritas Collagen Matrix (2006), cited by 5
- K030879: Veritas Collagen Matrix (2003), cited by 4
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement (2004), cited by 4
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), cited by 3
- K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD (2004), cited by 3
- K083039: Veritas Collagen Matrix (Dry) (2008), cited by 1

## Recent decisions
- K122306: Synovis Collagen Matrix (TBD) (Mar 8, 2013)
- K083039: Veritas Collagen Matrix (Dry) (Nov 26, 2008)
- K062915: Veritas Collagen Matrix (Dec 6, 2006)
- K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD (Oct 27, 2004)
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement (Apr 14, 2004)
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (Mar 17, 2004)
- K040001: Steerable Stylet (Mar 9, 2004)
- K030879: Veritas Collagen Matrix (Apr 24, 2003)

Source page: https://510kreport.com/company/synovis-surgical-innovations