ACCOLADE RPS HIP STEM

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 Accolade Rps Hip Stem.

Pre-market Notification Details

Device IDK052542
510k NumberK052542
Device Name:ACCOLADE RPS HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
ContactTiffani Rogers
CorrespondentTiffani Rogers
STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-15
Decision Date2005-09-27
Summary:summary

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