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 ID: K212737
• 510k Number: K212737
• Device Name: INHANCE™ Reverse Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Depuy Ireland UC Loughbeg Ringaskiddy, IE
• Contact: Yayoi Fujimaki
• Correspondent: Russ Parrott; Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: MBF
• Subsequent Product Code: PAO
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-30
• Decision Date: 2022-04-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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