Restoration Anatomic Shell

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

STRYKER ORTHOPAEDICS

The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Restoration Anatomic Shell.

Pre-market Notification Details

Device IDK142462
510k NumberK142462
Device Name:Restoration Anatomic Shell
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
ContactDenise Daugert
CorrespondentDenise Daugert
STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2014-11-14
Summary:summary

NIH GUDID Devices

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