INHANCETM Hybrid Anatomic Glenoid Implant

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Depuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Inhancetm Hybrid Anatomic Glenoid Implant.

Pre-market Notification Details

Device IDK212933
510k NumberK212933
Device Name:INHANCETM Hybrid Anatomic Glenoid Implant
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant Depuy Ireland UC Loughbeg Ringaskiddy,  IE
ContactYayoi Fujimaki
CorrespondentRuss Parrott
Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake,  IN  46590
Product CodeMBF  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodePAO
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-15
Decision Date2022-06-08

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