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FDA 510(k)

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS

K-Number: K113271 · 2012-05-18

ApplicantBiomet Manufacturing, Inc.
Decision Date2012-05-18
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2012-05-18 under 510(k) number K113271. 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 METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS?

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS is a medical device that received FDA 510(k) clearance on 2012-05-18. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K113271.

When did METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS receive FDA 510(k) clearance?

METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS received FDA 510(k) clearance on 2012-05-18, under 510(k) number K113271.

Who is the listed applicant for METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS?

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

What is the FDA product code for METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS?

The FDA product code for METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS is KWA.

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Other records listing Biomet Manufacturing, Inc. 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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEMK070399100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

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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 SHELLWrightmedicaltechnologyincK113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA 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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