INHANCETM Reverse Glenoid Peripheral Posts

Shoulder Prosthesis, Reverse Configuration

Depuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Inhancetm Reverse Glenoid Peripheral Posts.

Pre-market Notification Details

Device IDK221467
510k NumberK221467
Device Name:INHANCETM Reverse Glenoid Peripheral Posts
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Depuy Ireland UC Loughbeg Ringaskiddy,  IE
ContactYayoi Fujimaki
CorrespondentRuss Parrott
Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
Product CodePHX  
Subsequent Product CodeMBF
Subsequent Product CodePAO
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-20
Decision Date2022-08-31

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