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FDA 510(k)

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM

K-Number: K091926 · 2009-12-22

ApplicantChoicespine, LP
Decision Date2009-12-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2009-12-22 under 510(k) number K091926. 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 CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM?

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-22. The listed applicant is Choicespine, LP. The 510(k) number is K091926.

When did CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM receive FDA 510(k) clearance?

CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM received FDA 510(k) clearance on 2009-12-22, under 510(k) number K091926.

Who is the listed applicant for CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM?

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

What is the FDA product code for CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM?

The FDA product code for CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM is KWQ.

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Other records listing Choicespine, LP 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.

K190227Boomerang™ Anterior Cervical Plate SystemK183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK180519HARRIER-SA™ Lumbar Interbody SystemK172816TiGer Shark™ System

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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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