FOUNDATION NON-POROUS STEM

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 Non-porous Stem.

Pre-market Notification Details

Device IDK935449
510k NumberK935449
Device Name:FOUNDATION NON-POROUS STEM
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 Received1993-11-12
Decision Date1995-03-30

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