# Opus Medical, Inc.

- Location (FDA's records): San Juan Capistrano, CA
- FDA decisions: 13 (2001–2004): 13 510(k) clearances
- Product codes: OCW (4), MBI (3), HTY (2), GEX (2), GAT (1), HWC (1)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 21 (3 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Arthrocare Corp.: 7 (https://510kreport.com/company/arthrocare)
- Spectragenics, Inc.: 3 (https://510kreport.com/company/spectragenics)
- Kfx Medical: 2 (https://510kreport.com/company/kfx-medical)
- Arthocare Corporation: 2 (https://510kreport.com/company/arthocare)
- Johnson & Johnson: 1 (https://510kreport.com/company/johnson-johnson)
- Juniper Medical Technology, Inc.: 1 (https://510kreport.com/company/juniper-medical-technology)
- Cayenne Medical, Inc.: 1 (https://510kreport.com/company/cayenne-medical)
- Anulex Technologies, Inc.: 1 (https://510kreport.com/company/anulex-technologies)

## Its most-cited devices
- K012125: Opus Magnum Anchor & Inserter (2001), cited by 4
- K030235: F1 Diode Laser System (2003), cited by 4
- K042031: Opus Speedstitch Suture Device (2004), cited by 3
- K042584: Opus Minimagnum Anchor with Inserter (2004), cited by 3
- K042914: Opus Magnum Knotless Anchor with Inserter Handle (2004), cited by 3
- K033317: Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070 (2003), cited by 1

## Recent decisions
- K042584: Opus Minimagnum Anchor with Inserter (Dec 14, 2004)
- K042914: Opus Magnum Knotless Anchor with Inserter Handle (Nov 12, 2004)
- K042031: Opus Speedstitch Suture Device (Oct 19, 2004)
- K041440: Opus Magnum Anchor with Inserter (Jun 25, 2004)
- K033317: Smartstitch M-Connector, Model OM-8700; Needle Cassette, OM-8750; Autocuff System Instrument Set, OM-9070 (Dec 30, 2003)
- K030170: Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 (Jul 28, 2003)
- K031083: Opus Magnum Implant System, Model OM-1500 (Jun 12, 2003)
- K030235: F1 Diode Laser System (Apr 23, 2003)

Source page: https://510kreport.com/company/opus-medical