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FDA 510(k)

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K092531 · 2010-02-04

ApplicantSpine360
Decision Date2010-02-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine360. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K092531. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE360 ANTERIOR CERVICAL PLATE SYSTEM?

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Spine360. The 510(k) number is K092531.

When did SPINE360 ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SPINE360 ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2010-02-04, under 510(k) number K092531.

Who is the listed applicant for SPINE360 ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Spine360 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE360 ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SPINE360 ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spine360 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.

K102995TALON SPINAL SYSTEM

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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