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FDA 510(k)

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM

K-Number: K103838 · 2011-02-15

ApplicantPrecision Surgery , Ltd.
Decision Date2011-02-15
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Surgery , Ltd.. It received FDA 510(k) clearance on 2011-02-15 under 510(k) number K103838. 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 FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM?

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-15. The listed applicant is Precision Surgery , Ltd.. The 510(k) number is K103838.

When did FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2011-02-15, under 510(k) number K103838.

Who is the listed applicant for FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM?

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

What is the FDA product code for FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM?

The FDA product code for FIXED VARIABLE & CORPECTOMY 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.

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Other records listing Precision Surgery , Ltd. 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.

K103819PSL ANTERIOR CERVICAL PLATE SYSTEMK073708FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE 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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