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FDA 510(k)

CHARNLEY CONGENITAL HIP FEMUR (85-3061)

K-Number: K761003 · 1976-11-23

ApplicantCodman & Shurtleff, Inc.
Decision Date1976-11-23
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHARNLEY CONGENITAL HIP FEMUR (85-3061) is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1976-11-23 under 510(k) number K761003. 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 CHARNLEY CONGENITAL HIP FEMUR (85-3061)?

CHARNLEY CONGENITAL HIP FEMUR (85-3061) is a medical device that received FDA 510(k) clearance on 1976-11-23. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K761003.

When did CHARNLEY CONGENITAL HIP FEMUR (85-3061) receive FDA 510(k) clearance?

CHARNLEY CONGENITAL HIP FEMUR (85-3061) received FDA 510(k) clearance on 1976-11-23, under 510(k) number K761003.

Who is the listed applicant for CHARNLEY CONGENITAL HIP FEMUR (85-3061)?

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

What is the FDA product code for CHARNLEY CONGENITAL HIP FEMUR (85-3061)?

The FDA product code for CHARNLEY CONGENITAL HIP FEMUR (85-3061) is JDG.

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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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