# Sulzer Spine-Tech

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 8 (1999–2002): 7 510(k) clearances and 1 original PMA approval
- Product codes: KWP (3), MAX (1), MNI (1), JDK (1), KWQ (1), MNH (1)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 69 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spine-Tech, Inc.: 4 (https://510kreport.com/company/spine-tech)
- Signus Medizintechnik GmbH: 1 (https://510kreport.com/company/signus-medizintechnik)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)

## Firms that cite its devices most
- Zimmer Spine, Inc.: 6 (https://510kreport.com/company/zimmer-spine)
- Spinecraft, LLC: 2 (https://510kreport.com/company/spinecraft)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Genesys Spine: 2 (https://510kreport.com/company/genesys-spine)
- Centerpulse Spine-Tech, Inc.: 2 (https://510kreport.com/company/centerpulse-spine-tech)
- Wenzel Spine, Inc.: 2 (https://510kreport.com/company/wenzel-spine)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- K7, LLC: 1 (https://510kreport.com/company/k7)

## Its most-cited devices
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System (2001), cited by 54
- K992276: Modification to Silhouette Spinal Fixation System (1999), cited by 4
- K012305: Modification to: Trinica Anterior Cervical Plate System (2001), cited by 4
- K993067: Silhouette Spinal Fixation System (1999), cited by 3
- K022374: Cadence Spinal Fixation System (2002), cited by 3
- K020344: RPX Titanium Cemnt Restrictor (2002), cited by 1

## Recent decisions
- K022374: Cadence Spinal Fixation System (Sep 24, 2002)
- K020344: RPX Titanium Cemnt Restrictor (May 2, 2002)
- K020196: Modification to Silhouette Spinal Fixation System (Feb 15, 2002)
- K012173: Device Modification of Silhouette Spindal Fixation System (Sep 28, 2001)
- K012305: Modification to: Trinica Anterior Cervical Plate System (Aug 22, 2001)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System (Apr 20, 2001)
- K993067: Silhouette Spinal Fixation System (Nov 16, 1999)
- K992276: Modification to Silhouette Spinal Fixation System (Oct 1, 1999)

Source page: https://510kreport.com/company/sulzer-spine-tech