Stryker Orthopaedics Hip Systems Labeling Update

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 Stryker Orthopaedics Hip Systems Labeling Update.

Pre-market Notification Details

Device IDK153345
510k NumberK153345
Device Name:Stryker Orthopaedics Hip Systems Labeling Update
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
ContactMargaret Klippel
CorrespondentMargaret Klippel
STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
Product CodeLPH  
Subsequent Product CodeHWC
Subsequent Product CodeJDI
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeMAY
Subsequent Product CodeMBL
Subsequent Product CodeMEH
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-19
Decision Date2016-05-25
Summary:summary

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