PCA ALUMINA FEMORAL HEADS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

STRYKER ORTHOPAEDICS

The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Pca Alumina Femoral Heads.

Pre-market Notification Details

Device IDK063816
510k NumberK063816
Device Name:PCA ALUMINA FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
ContactPatricia Setti-laperch
CorrespondentPatricia Setti-laperch
STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-22
Decision Date2007-02-02
Summary:summary

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