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FDA 510(k)

ZIMMER POROLOCK MIS STEM

K-Number: K071723 · 2008-03-07

ApplicantZimmer GmbH
Decision Date2008-03-07
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER POROLOCK MIS 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 2008-03-07 under 510(k) number K071723. 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 ZIMMER POROLOCK MIS STEM?

ZIMMER POROLOCK MIS STEM is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Zimmer GmbH. The 510(k) number is K071723.

When did ZIMMER POROLOCK MIS STEM receive FDA 510(k) clearance?

ZIMMER POROLOCK MIS STEM received FDA 510(k) clearance on 2008-03-07, under 510(k) number K071723.

Who is the listed applicant for ZIMMER POROLOCK MIS 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 ZIMMER POROLOCK MIS STEM?

The FDA product code for ZIMMER POROLOCK MIS STEM is KWA.

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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.

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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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