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FDA 510(k)

AVENIR CEMENTED HIP STEM

K-Number: K131884 · 2013-08-22

ApplicantZimmer GmbH
Decision Date2013-08-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVENIR CEMENTED HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131884. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVENIR CEMENTED HIP STEM?

AVENIR CEMENTED HIP STEM is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Zimmer GmbH. The 510(k) number is K131884.

When did AVENIR CEMENTED HIP STEM receive FDA 510(k) clearance?

AVENIR CEMENTED HIP STEM received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131884.

Who is the listed applicant for AVENIR CEMENTED HIP STEM?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVENIR CEMENTED HIP STEM?

The FDA product code for AVENIR CEMENTED HIP STEM is LZO.

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Other records listing Zimmer GmbH 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.

K211047CoCr HeadK200814Affixus(R) Natural Nail(R) System Humeral NailK200112Zimmer Hip Joint ReplacementK193099Anatomical Shoulder SystemK193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemK193030Avenir Muller Stem, Avenir Cemented Hip Stem

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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