Integra TITAN Reverse Shoulder System

Shoulder Prosthesis, Reverse Configuration

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Titan Reverse Shoulder System.

Pre-market Notification Details

Device IDK161189
510k NumberK161189
Device Name:Integra TITAN Reverse Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant INTEGRA LIFESCIENCES CORPORATION 8700 CAMERON ROAD, SUITE 100 Austin,  TX  78754
ContactWilliam Garzon
CorrespondentWilliam Garzon
INTEGRA LIFESCIENCES CORPORATION 8700 CAMERON ROAD, SUITE 100 Austin,  TX  78754
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-27
Decision Date2016-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556863510 K161189 000

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