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FDA 510(k)

Z-LINKPC System

K-Number: K162575 · 2017-03-03

ApplicantZavation, LLC
Decision Date2017-03-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z-LINKPC System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162575. 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 Z-LINKPC System?

Z-LINKPC System is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Zavation, LLC. The 510(k) number is K162575.

When did Z-LINKPC System receive FDA 510(k) clearance?

Z-LINKPC System received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162575.

Who is the listed applicant for Z-LINKPC System?

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

What is the FDA product code for Z-LINKPC System?

The FDA product code for Z-LINKPC System is NKG.

Other records listing Zavation, LLC 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.

K162206Zavation IBFK162824Z-Span Plate SystemK161016Z-Clamp ISP SystemK153404Zavation Spinal SystemK160362Z-Span Plate System

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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