# Smith and Nephew Donjoy, Inc.

- Location (FDA's records): Carsbad, CA
- FDA decisions: 15 (1991–1997): 15 510(k) clearances
- Product codes: HWC (4), FMQ (3), GZJ (2), HCC (2), HRX (1), IPF (1), KGX (1), ILO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)

## Its most-cited devices
- K945687: Rounded Cannulated Inside-Out (Rci) Acl Screw (1995), cited by 2

## Recent decisions
- K970051: Musclesense II Clinical Electromyography Device (Jul 10, 1997)
- K963490: Protective Restraint - Belts (Nov 12, 1996)
- K963489: Wheel Chair Accessory (Nov 12, 1996)
- K963492: Protective Restraint (Nov 12, 1996)
- K962462: Musclemax Plus Electrical Muscle Stimulator (Sep 23, 1996)
- K955057: Model 1100 Cold Therapy Device (Mar 8, 1996)
- K951350: Musclesense Electromyography Device (Jun 23, 1995)
- K945687: Rounded Cannulated Inside-Out (Rci) Acl Screw (Jun 22, 1995)

Source page: https://510kreport.com/company/smith-and-nephew-donjoy