# Spinal Concepts, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 33 (1997–2005): 33 510(k) clearances
- Product codes: MNI (5), KWQ (5), JDK (5), KWP (5), MQP (5), NKB (2), MNH (2), JDQ (1), HRS (1), GZT (1), HWC (1)
- Predicates its devices cite: 42 (16 its own); citations of its devices by later devices: 78 (16 its own)
- Recalls linked to its devices: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Interpore Cross Intl.: 5 (https://510kreport.com/company/interpore-cross-intl)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Sofamor Danek Mfg., Inc.: 2 (https://510kreport.com/company/sofamor-danek-mfg)
- Sofamor Danek USA,Inc.: 2 (https://510kreport.com/company/sofamor-danek-usa)
- Signus Medical, LLC: 2 (https://510kreport.com/company/signus-medical)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Blackstone Medical, Inc.: 1 (https://510kreport.com/company/blackstone-medical)

## Firms that cite its devices most
- Zimmer Spine, Inc.: 10 (https://510kreport.com/company/zimmer-spine)
- Abbott Spine, Inc.: 10 (https://510kreport.com/company/abbott-spine)
- Novaspine, LLC: 3 (https://510kreport.com/company/novaspine)
- Innovasis, Inc.: 3 (https://510kreport.com/company/innovasis)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- L&K BIOMED Co., Ltd.: 2 (https://510kreport.com/company/l-k-biomed)
- Signature Orthopaedics Pty, Ltd.: 2 (https://510kreport.com/company/signature-orthopaedics)
- Ebi, L.P.: 2 (https://510kreport.com/company/ebi)

## Its most-cited devices
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System (2003), cited by 10
- K021564: Incompass Spinal Fixation System (2002), cited by 7
- K033517: Spinal Concepts Inc. Cadence and Traxis (2004), cited by 6
- K030625: Spinal Concepts Inc. Pathfinder (2003), cited by 6
- K031672: Spinal Concepts, Inc. Infix System (2003), cited by 6
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System (1999), cited by 5

## Recent decisions
- K051000: Fortitude Vue Vertebral Body Replacement Device (May 19, 2005)
- K050706: Harmony Port System, Model 1907 Series (Apr 15, 2005)
- K040096: Spinal Concepts, Inc. Tandem Spinous Process Plate System (Jul 1, 2004)
- K033663: Spinal Concepts Inc. Coda (May 27, 2004)
- K033517: Spinal Concepts Inc. Cadence and Traxis (Feb 18, 2004)
- K031855: Spinal Concepts, Inc. Insight Pedicle Screw System (Sep 17, 2003)
- K031985: Spinal Concepts Inc. Nex-Link Spinal Fixation System (Sep 11, 2003)
- K031318: Traxis Cement Restrictor (Aug 22, 2003)

Source page: https://510kreport.com/company/spinal-concepts