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FDA 510(k)

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM

K-Number: K043547 · 2005-08-05

ApplicantBiomet, Inc.
Decision Date2005-08-05
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K043547. 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 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM?

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Biomet, Inc.. The 510(k) number is K043547.

When did COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM receive FDA 510(k) clearance?

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM received FDA 510(k) clearance on 2005-08-05, under 510(k) number K043547.

Who is the listed applicant for COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM?

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 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM?

The FDA product code for COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM is KWA.

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Other records listing Biomet, Inc. as applicant

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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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