Comprehensive Reverse Shoulder System

Shoulder Prosthesis, Reverse Configuration

Biomet Manufacturing Corp

The following data is part of a premarket notification filed by Biomet Manufacturing Corp with the FDA for Comprehensive Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K181611
• 510k Number: K181611
• Device Name: Comprehensive Reverse Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Biomet Manufacturing Corp 56 East Bell Drive Warsaw, IN 46580
• Contact: Dalene Binkley
• Correspondent: Dalene Binkley; ZIMMER INC. 345 E. MAIN ST. Warsaw, IN 46580
• Product Code: PHX
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• Subsequent Product Code: PAO
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-19
• Decision Date: 2018-09-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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