# Zimmer Spine, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 44 (1996–2016): 43 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Zimmer Spine, Inc. (39); Zimmer Spine (5)
- Product codes: NKB (13), KWQ (7), NQP (7), MAX (5), OWI (2), KWP (2), NKG (2), JDQ (1), OVE (1), MNI (1), ODP (1), MNH (1)
- Predicates its devices cite: 127 (32 its own); citations of its devices by later devices: 138 (32 its own)
- Recalls linked to its devices: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Spine, Inc.: 20 (https://510kreport.com/company/abbott-spine)
- Spinal Concepts, Inc.: 10 (https://510kreport.com/company/spinal-concepts)
- Endius, Inc.: 9 (https://510kreport.com/company/endius)
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- Zimmer Trabecular Metal Technology: 7 (https://510kreport.com/company/zimmer-trabecular-metal-technology)
- Sulzer Spine-Tech: 6 (https://510kreport.com/company/sulzer-spine-tech)
- Centerpulse Spine-Tech, Inc.: 5 (https://510kreport.com/company/centerpulse-spine-tech)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- Medicrea International SA: 4 (https://510kreport.com/company/medicrea-international)
- Titan Spine, LLC: 4 (https://510kreport.com/company/titan-spine)
- K2m, Inc.: 4 (https://510kreport.com/company/k2m)
- Osseus Fusion Systems, LLC: 4 (https://510kreport.com/company/osseus-fusion-systems)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Astura Medical: 3 (https://510kreport.com/company/astura-medical)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)

## Its most-cited devices
- P950002: Bak Interbody Fusion System (1996), cited by 35
- K153631: Zimmer Virage OCT Spinal Fixation System (2016), cited by 10
- K110348: Universal Clamp Spinal Fixation System (2011), cited by 9
- K111119: Trabecular Metal (TM) Fusion Device (2011), cited by 6
- K142053: Universal Clamp Spinal Fixation System (2014), cited by 5
- K132790: Infix Anterior Lumbar System (2013), cited by 5

## Recent decisions
- K153631: Zimmer Virage OCT Spinal Fixation System (Feb 16, 2016)
- K150896: Vitality Spinal Fixation System (Aug 31, 2015)
- K151031: Virage OCT Spinal Fixation System (Jun 24, 2015)
- K142752: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (Jun 18, 2015)
- K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System (Mar 20, 2015)
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (Feb 12, 2015)
- K142053: Universal Clamp Spinal Fixation System (Oct 29, 2014)
- K141500: Optio-C Anterior Cervical System (Sep 23, 2014)

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