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FDA 510(k)

SWIFT ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K040655 · 2004-06-02

ApplicantDepuy Spine, Inc.
Decision Date2004-06-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SWIFT 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 2004-06-02 under 510(k) number K040655. 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 SWIFT ANTERIOR CERVICAL PLATE SYSTEM?

SWIFT ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K040655.

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

SWIFT ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2004-06-02, under 510(k) number K040655.

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

The FDA product code for SWIFT 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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