TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

STRYKER ORTHOPAEDICS

The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Knee System Posterior Stabilized Components.

Pre-market Notification Details

Device IDK141056
510k NumberK141056
Device Name:TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
ContactKaren Ariemma
CorrespondentKaren Ariemma
STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah,  NJ  07430
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-24
Decision Date2014-08-05
Summary:summary

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