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FDA 510(k)

INTEGRAL CO-CR FEMORAL COMPONENT

K-Number: K942479 · 1994-09-20

ApplicantBiomet, Inc.
Decision Date1994-09-20
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRAL CO-CR FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K942479. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRAL CO-CR FEMORAL COMPONENT?

INTEGRAL CO-CR FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Biomet, Inc.. The 510(k) number is K942479.

When did INTEGRAL CO-CR FEMORAL COMPONENT receive FDA 510(k) clearance?

INTEGRAL CO-CR FEMORAL COMPONENT received FDA 510(k) clearance on 1994-09-20, under 510(k) number K942479.

Who is the listed applicant for INTEGRAL CO-CR FEMORAL COMPONENT?

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 INTEGRAL CO-CR FEMORAL COMPONENT?

The FDA product code for INTEGRAL CO-CR FEMORAL COMPONENT is JDG.

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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: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast CompanyK992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USAK962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.

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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