INHANCE™ Reverse Shoulder System

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 Inhance™ Reverse Shoulder System.

Pre-market Notification Details

Device IDK212737
510k NumberK212737
Device Name:INHANCE™ Reverse Shoulder System
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 CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
Subsequent Product CodePAO
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-30
Decision Date2022-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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Trademark Results [INHANCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INHANCE
INHANCE
97225420 not registered Live/Pending
Balchem Corporation
2022-01-18
INHANCE
INHANCE
90611591 not registered Live/Pending
Johnson & Johnson
2021-03-30
INHANCE
INHANCE
88559993 not registered Live/Pending
Alastin Skincare, Inc.
2019-08-01
INHANCE
INHANCE
88444166 not registered Live/Pending
Ingenia Polymers International S.A.
2019-05-23
INHANCE
INHANCE
87169163 not registered Live/Pending
Hollingsworth & Vose Company
2016-09-13
INHANCE
INHANCE
85822139 4433924 Live/Registered
Inhance Development Group, LLC
2013-01-14
INHANCE
INHANCE
85809513 4627023 Live/Registered
ImageCat, Inc.
2012-12-21
INHANCE
INHANCE
78875256 not registered Dead/Abandoned
Inhance Digital Corp.
2006-05-03
INHANCE
INHANCE
77002637 not registered Dead/Abandoned
Inhance Media, Inc.
2006-09-19
INHANCE
INHANCE
76568060 not registered Dead/Abandoned
Essaic Products Inc.
2003-12-22
INHANCE
INHANCE
76315036 2873145 Dead/Cancelled
FLUORO-INTERESTS INTERESTS, LP
2001-09-20
INHANCE
INHANCE
76043536 not registered Dead/Abandoned
INHALE THERAPEUTIC SYSTEMS, INC.
2000-05-04

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