Comprehensive® Reverse Shoulder

Shoulder Prosthesis, Reverse Configuration

Biomet Inc.

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

Pre-market Notification Details

• Device ID: K193373
• 510k Number: K193373
• Device Name: Comprehensive® Reverse Shoulder
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581
• Contact: Kari Hovorka
• Correspondent: Kari Hovorka; Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-05
• Decision Date: 2020-04-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868470103	K193373	000
00887868504679	K193373	000
00887868504754	K193373	000
00887868504778	K193373	000
00887868391088	K193373	000
00887868504587	K193373	000
00887868505102	K193373	000
00889024646254	K193373	000
00887868504594	K193373	000
00887868504709	K193373	000
00880304509733	K193373	000
00880304469747	K193373	000
00880304469778	K193373	000
00880304469891	K193373	000
00880304469976	K193373	000
00880304471191	K193373	000
00887868504655	K193373	000