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FDA 510(k)

DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

K-Number: K053536 · 2006-03-16

ApplicantZimmer GmbH
Decision Date2006-03-16
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER 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 2006-03-16 under 510(k) number K053536. 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 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS?

DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Zimmer GmbH. The 510(k) number is K053536.

When did DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS receive FDA 510(k) clearance?

DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS received FDA 510(k) clearance on 2006-03-16, under 510(k) number K053536.

Who is the listed applicant for DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER 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 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS?

The FDA product code for DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER 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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