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FDA 510(k)

Certex Spinal Fixation System

K-Number: K160428 · 2016-05-05

ApplicantX-Spine Systems, Inc.
Decision Date2016-05-05
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Certex Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160428. 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 Certex Spinal Fixation System?

Certex Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K160428.

When did Certex Spinal Fixation System receive FDA 510(k) clearance?

Certex Spinal Fixation System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160428.

Who is the listed applicant for Certex Spinal Fixation System?

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

What is the FDA product code for Certex Spinal Fixation System?

The FDA product code for Certex Spinal Fixation System is NKG.

Other records listing X-Spine Systems, Inc. as applicant

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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

View on FDA Database →

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

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