# Sofamor Danek USA,Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 42 (1995–2000): 42 510(k) clearances
- Names in FDA's records: Sofamor Danek USA,Inc. (41); Sofamor Danek USA (1)
- Product codes: KWP (13), MNH (9), KWQ (7), MNI (5), HRX (4), JEY (1), GWG (1), HRS (1), MRW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 95 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Medtronic Sofamor Danek: 20 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 8 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Bioplate, Inc.: 7 (https://510kreport.com/company/bioplate)
- Aesculap, Inc.: 5 (https://510kreport.com/company/aesculap)
- CarboFix Orthopedics, Ltd.: 4 (https://510kreport.com/company/carbofix-orthopedics)
- Ebi, L.P.: 4 (https://510kreport.com/company/ebi)
- Scien'Tx USA, Inc.: 3 (https://510kreport.com/company/scien-tx-usa)
- Reliance Medical Systems, LLC: 3 (https://510kreport.com/company/reliance-medical-systems)

## Its most-cited devices
- K981676: CD Horizon Spinal System (1999), cited by 18
- K961633: CD Horizon Spinal System (1996), cited by 11
- K982990: TSRH Spinal System (1998), cited by 8
- K973854: Orion Anterior Cervical Plate System (1998), cited by 7
- K974017: Timesh System (1998), cited by 7
- K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System (1997), cited by 5

## Recent decisions
- K991031: Colorado II Spinal System (May 10, 2000)
- K984360: Colorado II Spinal System (Mar 30, 2000)
- K992928: CD Horizon Spinal System (Sep 21, 1999)
- K991036: Danek Plate and Screw System (Sep 14, 1999)
- K992110: Premier Anterior Cervical Plate System (Sep 14, 1999)
- K991198: Dyna-Lok Plus  Spinal System (Aug 27, 1999)
- K991364: Modification to Tenor Spinal System-Plates (May 19, 1999)
- K981676: CD Horizon Spinal System (Jan 28, 1999)

Source page: https://510kreport.com/company/sofamor-danek-usa