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FDA 510(k)

PROFEMUR GLADIATOR HA HIP STEM

K-Number: K112150 · 2011-11-23

ApplicantWrightmedicaltechnologyinc
Decision Date2011-11-23
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR GLADIATOR HA 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 2011-11-23 under 510(k) number K112150. 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 GLADIATOR HA HIP STEM?

PROFEMUR GLADIATOR HA HIP STEM is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K112150.

When did PROFEMUR GLADIATOR HA HIP STEM receive FDA 510(k) clearance?

PROFEMUR GLADIATOR HA HIP STEM received FDA 510(k) clearance on 2011-11-23, under 510(k) number K112150.

Who is the listed applicant for PROFEMUR GLADIATOR HA 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 GLADIATOR HA HIP STEM?

The FDA product code for PROFEMUR GLADIATOR HA 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 STEMWrightmedicaltechnologyincK113019PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZERWrightmedicaltechnologyinc

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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