# Zimmer Biomet Spine, Inc.

- Location (FDA's records): Westminister, CO
- FDA decisions: 15 (2017–2021): 15 510(k) clearances
- Product codes: NKB (5), OLO (4), OVD (2), MQV (1), KWQ (1), MAX (1), PGM (1)
- 510(k) review time since 2016: median 79 days, against 90 for FDA's reviews in the same codes and years (7 of 14 faster)
- Predicates its devices cite: 34 (2 its own); citations of its devices by later devices: 18 (2 its own)
- Recalls linked to its devices: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet Spine: 5 (https://510kreport.com/company/biomet-spine)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Lanx, Inc.: 3 (https://510kreport.com/company/lanx)
- Medtronic Navigation, Inc.: 2 (https://510kreport.com/company/medtronic-navigation)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Zimmer Spine, Inc.: 2 (https://510kreport.com/company/zimmer-spine)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Zimvie Spine (Zimmer Biomet Spine, Inc.): 3 (https://510kreport.com/company/zimvie-spine-zimmer-biomet-spine)
- Zimvie (Zimmer Biomet Spine, Inc.): 2 (https://510kreport.com/company/zimvie-zimmer-biomet-spine)
- Astura Medical: 2 (https://510kreport.com/company/astura-medical)
- Spineology, Inc.: 1 (https://510kreport.com/company/spineology)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- Lock-In USA Corp: 1 (https://510kreport.com/company/lock-in-usa)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Spineart: 1 (https://510kreport.com/company/spineart)

## Its most-cited devices
- K163543: Biomet Fusion System (2017), cited by 6
- K203507: Vitality® Spinal Fixation System (2021), cited by 3
- K171907: Vitality® Spinal Fixation System (2017), cited by 3
- K191722: Vital Navigation System (2019), cited by 2
- K212023: Virage Navigation System (2021), cited by 1
- K183550: Vitality® Spinal Fixation System (2019), cited by 1

## Recent decisions
- K212023: Virage Navigation System (Aug 27, 2021)
- K203218: CaP Spheres Pellet Pack (May 4, 2021)
- K210275: Polaris Spinal System (Apr 2, 2021)
- K203507: Vitality® Spinal Fixation System (Jan 28, 2021)
- K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (Oct 8, 2020)
- K191722: Vital Navigation System (Dec 2, 2019)
- K192133: Zimmer Biomet Universal Navigation System (Oct 29, 2019)
- K190556: Zimmer Biomet Universal Navigation System (Oct 24, 2019)

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