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FDA 510(k)

TAPERLOC COMPLETE

K-Number: K101086 · 2010-09-03

ApplicantBiomet, Inc.
Decision Date2010-09-03
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TAPERLOC COMPLETE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K101086. 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 TAPERLOC COMPLETE?

TAPERLOC COMPLETE is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Biomet, Inc.. The 510(k) number is K101086.

When did TAPERLOC COMPLETE receive FDA 510(k) clearance?

TAPERLOC COMPLETE received FDA 510(k) clearance on 2010-09-03, under 510(k) number K101086.

Who is the listed applicant for TAPERLOC COMPLETE?

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

What is the FDA product code for TAPERLOC COMPLETE?

The FDA product code for TAPERLOC COMPLETE is KWA.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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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