SELF-CENTERING HIP

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Self-centering Hip.

Pre-market Notification Details

Device IDK812672
510k NumberK812672
Device Name:SELF-CENTERING HIP
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant DEPUY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-22
Decision Date1981-10-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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