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FDA 510(k)

BRIDALVEIL Occipital Cervical Thoracic System

K-Number: K171250 · 2017-10-02

ApplicantAstura Medical
Decision Date2017-10-02
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BRIDALVEIL Occipital Cervical Thoracic System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171250. 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 BRIDALVEIL Occipital Cervical Thoracic System?

BRIDALVEIL Occipital Cervical Thoracic System is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Astura Medical. The 510(k) number is K171250.

When did BRIDALVEIL Occipital Cervical Thoracic System receive FDA 510(k) clearance?

BRIDALVEIL Occipital Cervical Thoracic System received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171250.

Who is the listed applicant for BRIDALVEIL Occipital Cervical Thoracic System?

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

What is the FDA product code for BRIDALVEIL Occipital Cervical Thoracic System?

The FDA product code for BRIDALVEIL Occipital Cervical Thoracic System is NKG.

Related Clinical Trials

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NCT05489822PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.TERMINATED

Other records listing Astura Medical 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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