FOUNDATION ALL POLY CUP

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

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation All Poly Cup.

Pre-market Notification Details

Device IDK934169
510k NumberK934169
Device Name:FOUNDATION ALL POLY CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin,  TX  78759
ContactJ.d. Webb
CorrespondentJ.d. Webb
ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin,  TX  78759
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-27
Decision Date1994-05-03

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