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FDA 510(k)

HYBRID ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K052552 · 2005-10-13

ApplicantDepuy Spine, Inc.
Decision Date2005-10-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYBRID ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2005-10-13 under 510(k) number K052552. 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 HYBRID ANTERIOR CERVICAL PLATE SYSTEM?

HYBRID ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-13. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K052552.

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

HYBRID ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2005-10-13, under 510(k) number K052552.

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

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

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

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

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Other records listing Depuy Spine, Inc. as applicant

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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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