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FDA 510(k)

Zimmer Virage OCT Spinal Fixation System

K-Number: K153631 · 2016-02-16

ApplicantZimmer Spine, Inc.
Decision Date2016-02-16
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Virage OCT Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153631. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Virage OCT Spinal Fixation System?

Zimmer Virage OCT Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K153631.

When did Zimmer Virage OCT Spinal Fixation System receive FDA 510(k) clearance?

Zimmer Virage OCT Spinal Fixation System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153631.

Who is the listed applicant for Zimmer Virage OCT Spinal Fixation System?

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

What is the FDA product code for Zimmer Virage OCT Spinal Fixation System?

The FDA product code for Zimmer Virage OCT Spinal Fixation System is NKG.

Related Devices (Code: NKG)

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.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

Official Source

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

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