Comprehensive® Convertible Glenoid - Vivacit-E Liner

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® Convertible Glenoid - Vivacit-e Liner.

Pre-market Notification Details

• Device ID: K211729
• 510k Number: K211729
• Device Name: Comprehensive® Convertible Glenoid - Vivacit-E Liner
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582
• Product Code: PHX
• 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: 2021-06-04
• Decision Date: 2021-11-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868249334	K211729	000