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FDA 510(k)

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K081132 · 2008-07-14

ApplicantSpine Smith Partners L.P.
Decision Date2008-07-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Smith Partners L.P.. It received FDA 510(k) clearance on 2008-07-14 under 510(k) number K081132. 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 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM?

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-14. The listed applicant is Spine Smith Partners L.P.. The 510(k) number is K081132.

When did SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2008-07-14, under 510(k) number K081132.

Who is the listed applicant for SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Spine Smith Partners L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Spine Smith Partners L.P. 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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