Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Virage® Navigation System

K-Number: K240647 · 2024-04-05

ApplicantZimvie Spine (Zimmer Biomet Spine, Inc.)
Decision Date2024-04-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Virage® Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimvie Spine (Zimmer Biomet Spine, Inc.). It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K240647. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virage® Navigation System?

Virage® Navigation System is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Zimvie Spine (Zimmer Biomet Spine, Inc.). The 510(k) number is K240647.

When did Virage® Navigation System receive FDA 510(k) clearance?

Virage® Navigation System received FDA 510(k) clearance on 2024-04-05, under 510(k) number K240647.

Who is the listed applicant for Virage® Navigation System?

The FDA 510(k) record lists Zimvie Spine (Zimmer Biomet Spine, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virage® Navigation System?

The FDA product code for Virage® Navigation System is OLO.

Other records listing Zimvie Spine (Zimmer Biomet Spine, Inc.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240539Vital™ Spinal Fixation SystemK233443Vital™ Navigation SystemK230116Vital™ Spinal Fixation System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑