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 IDK181999
510k NumberK181999
Device Name:Integra TITAN Reverse Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Integra Lifesciences Corporation 11101 Metric Blvd. Austin,  TX  78758
ContactBlesson Abraham
CorrespondentBlesson Abraham
Integra Lifesciences Corporation 11101 Metric Blvd. Austin,  TX  78758
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-26
Decision Date2018-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556864401 K181999 000
00885556863794 K181999 000
00885556863800 K181999 000
00885556863817 K181999 000
00885556863824 K181999 000
00885556864418 K181999 000
00885556864425 K181999 000
10381780489177 K181999 000
00885556864432 K181999 000
00885556864449 K181999 000
00885556864456 K181999 000
00885556864463 K181999 000
00885556864470 K181999 000
00885556864487 K181999 000
00885556860281 K181999 000

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