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FDA 510(k)

PROFEMUR(R) E CEMENTLESS HIP STEM

K-Number: K111698 · 2011-08-19

ApplicantWrightmedicaltechnologyinc
Decision Date2011-08-19
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR(R) E CEMENTLESS HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111698. 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 PROFEMUR(R) E CEMENTLESS HIP STEM?

PROFEMUR(R) E CEMENTLESS HIP STEM is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K111698.

When did PROFEMUR(R) E CEMENTLESS HIP STEM receive FDA 510(k) clearance?

PROFEMUR(R) E CEMENTLESS HIP STEM received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111698.

Who is the listed applicant for PROFEMUR(R) E CEMENTLESS HIP STEM?

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

What is the FDA product code for PROFEMUR(R) E CEMENTLESS HIP STEM?

The FDA product code for PROFEMUR(R) E CEMENTLESS HIP STEM 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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