COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE

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-mini Baseplate.

Pre-market Notification Details

• Device ID: K120121
• 510k Number: K120121
• Device Name: COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Beres
• Correspondent: Patricia Beres; BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-17
• Decision Date: 2012-02-16
• Summary: summary

Recalls

Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate With Taper Adapter

Zimmer Biomet, Inc.

2018-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304990135	K120121	000
00889024582897	K120121	000
00889024583139	K120121	000
00889024584693	K120121	000
00889024498013	K120121	000
00887868259067	K120121	000
00887868251405	K120121	000
00887868469947	K120121	000
00887868363351	K120121	000
00887868504600	K120121	000
00887868470110	K120121	000
00887868505119	K120121	000
00887868505140	K120121	000
00887868505133	K120121	000
00887868504808	K120121	000
00887868505126	K120121	000
00880304532274	K120121	000
00880304532281	K120121	000
00880304865433	K120121	000
00880304848351	K120121	000
00880304848238	K120121	000
00880304737266	K120121	000
00880304731523	K120121	000
00880304550476	K120121	000
00880304532465	K120121	000
00880304532366	K120121	000
00880304532359	K120121	000
00880304532342	K120121	000
00880304532335	K120121	000
00880304532328	K120121	000
00880304532311	K120121	000
00880304532304	K120121	000
00880304532298	K120121	000
00887868504785	K120121	000