INTERPLANTA SP TOTAL HIP PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

WALDEMAR LINK GMBH & CO. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Interplanta Sp Total Hip Prosthesis.

Pre-market Notification Details

Device IDK790488
510k NumberK790488
Device Name:INTERPLANTA SP TOTAL HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant WALDEMAR LINK GMBH & CO. KG 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-12
Decision Date1979-03-28

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