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FDA 510(k)

COMET ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K090751 · 2009-10-23

ApplicantApollo Spine, Inc.
Decision Date2009-10-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMET ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Spine, Inc.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K090751. 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 COMET ANTERIOR CERVICAL PLATE SYSTEM?

COMET ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Apollo Spine, Inc.. The 510(k) number is K090751.

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

COMET ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2009-10-23, under 510(k) number K090751.

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

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

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

The FDA product code for COMET ANTERIOR 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 Apollo Spine, Inc. 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.

K120340VENUS FACET SCREW SYSTEMK102636ZENITH PEDICLE SYSTEMK102121ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBARK101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICALK082504APOLLO ANTERIOR 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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