Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-Apatite

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

Howmedica Osteonics Corp.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-apatite.

Pre-market Notification Details

Device IDK200782
510k NumberK200782
Device Name:Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-Apatite
ClassificationProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Applicant Howmedica Osteonics Corp. 325 Corporate Drive Mahwah,  NJ  07430
ContactNora O'connor
CorrespondentNora O'connor
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeMBH  
CFR Regulation Number888.3565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-26
Decision Date2020-05-13

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