Virage Navigation System— 510(k) K212023
Substantially EquivalentZimmer Biomet Spine, Inc.
FDA 510(k) clearance K212023 for Virage Navigation System, Substantially Equivalent on 2021-08-27. Applicant: Zimmer Biomet Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Biomet Spine, Inc.
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminister, CO, US
Recent devices under product code OLO
view allMore clearances from Zimmer Biomet Spine, Inc.
view all- K203218 — CaP Spheres Pellet Pack
- K210275 — Polaris Spinal System
- K203507 — Vitality® Spinal Fixation System
- 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
- K191722 — Vital Navigation System
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.