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FDA 510(k)

ANTEGRA-T

K-Number: K081568 · 2008-09-02

ApplicantSynthes Spine Co.Lp
Decision Date2008-09-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTEGRA-T is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine Co.Lp. It received FDA 510(k) clearance on 2008-09-02 under 510(k) number K081568. 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 ANTEGRA-T?

ANTEGRA-T is a medical device that received FDA 510(k) clearance on 2008-09-02. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K081568.

When did ANTEGRA-T receive FDA 510(k) clearance?

ANTEGRA-T received FDA 510(k) clearance on 2008-09-02, under 510(k) number K081568.

Who is the listed applicant for ANTEGRA-T?

The FDA 510(k) record lists Synthes Spine Co.Lp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTEGRA-T?

The FDA product code for ANTEGRA-T is KWQ.

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Other records listing Synthes Spine Co.Lp 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.

K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)K112459SYNTHES ZERO-PK112068SYNTHES ZERO-P VARIABLE ANGLE (VA)K103320SYNTHES XRLK080020ARCOFIXK072981SYNTHES ZERO-P

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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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