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FDA 510(k)

METASUL TAPER LINERS, METASUL FEMORAL HEADS

K-Number: K091973 · 2009-11-17

ApplicantZimmer GmbH
Decision Date2009-11-17
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METASUL TAPER LINERS, METASUL FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2009-11-17 under 510(k) number K091973. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METASUL TAPER LINERS, METASUL FEMORAL HEADS?

METASUL TAPER LINERS, METASUL FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Zimmer GmbH. The 510(k) number is K091973.

When did METASUL TAPER LINERS, METASUL FEMORAL HEADS receive FDA 510(k) clearance?

METASUL TAPER LINERS, METASUL FEMORAL HEADS received FDA 510(k) clearance on 2009-11-17, under 510(k) number K091973.

Who is the listed applicant for METASUL TAPER LINERS, METASUL FEMORAL HEADS?

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 METASUL TAPER LINERS, METASUL FEMORAL HEADS?

The FDA product code for METASUL TAPER LINERS, METASUL FEMORAL HEADS is KWA.

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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