Comprehensive Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

Biomet Manufacturing Corp.

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

Pre-market Notification Details

• Device ID: K193038
• 510k Number: K193038
• Device Name: Comprehensive Shoulder System
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
• Applicant: Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580
• Product Code: MBF
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3670 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-31
• Decision Date: 2020-10-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887868506055	K193038	000
00887868505348	K193038	000
00887868505355	K193038	000
00887868505362	K193038	000
00887868505379	K193038	000
00887868505386	K193038	000
00887868505393	K193038	000
00887868505409	K193038	000
00887868505416	K193038	000
00887868505423	K193038	000
00887868505430	K193038	000
00887868505447	K193038	000
00887868505454	K193038	000
00887868505331	K193038	000
00887868505324	K193038	000
00887868505317	K193038	000
00887868506086	K193038	000
00887868506093	K193038	000
00887868506109	K193038	000
00887868479441	K193038	000
00887868479458	K193038	000
00887868479472	K193038	000
00887868479489	K193038	000
00887868479496	K193038	000
00887868479502	K193038	000
00887868505287	K193038	000
00887868505294	K193038	000
00887868505300	K193038	000
00887868479465	K193038	000
00880304367050	K193038	000
00880304367067	K193038	000
00880304433946	K193038	000
00880304433953	K193038	000
00880304433960	K193038	000
00880304434080	K193038	000
00880304447226	K193038	000
00880304456648	K193038	000
00880304461444	K193038	000
00880304367166	K193038	000
00880304431904	K193038	000
00880304433724	K193038	000
00880304456877	K193038	000
00880304456884	K193038	000
00880304431201	K193038	000
00880304430891	K193038	000
00880304430884	K193038	000
00880304367074	K193038	000
00880304367081	K193038	000
00880304367098	K193038	000
00880304367104	K193038	000
00880304367111	K193038	000
00880304367128	K193038	000
00880304367135	K193038	000
00880304367142	K193038	000
00880304367159	K193038	000
00880304367197	K193038	000
00880304430860	K193038	000
00880304430877	K193038	000
00880304456891	K193038	000