NEW ZIMMER SHOULDER SYSTEM

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for New Zimmer Shoulder System.

Pre-market Notification Details

• Device ID: K982981
• 510k Number: K982981
• Device Name: NEW ZIMMER SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Laura D Williams
• Correspondent: Laura D Williams; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-26
• Decision Date: 1998-12-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024264281	K982981	000
00889024263895	K982981	000
00889024263864	K982981	000
00889024263857	K982981	000
00889024263840	K982981	000
00889024263833	K982981	000
00889024263826	K982981	000
00889024263819	K982981	000
00889024263802	K982981	000
00889024263796	K982981	000
00889024263789	K982981	000
00889024263772	K982981	000
00889024263765	K982981	000
00889024263758	K982981	000
00889024263741	K982981	000
00889024632967	K982981	000
00889024632950	K982981	000
00889024263901	K982981	000
00889024263918	K982981	000
00889024264274	K982981	000
00889024264267	K982981	000
00889024264168	K982981	000
00889024264151	K982981	000
00889024264144	K982981	000
00889024264137	K982981	000
00889024264069	K982981	000
00889024264052	K982981	000
00889024264045	K982981	000
00889024263987	K982981	000
00889024263970	K982981	000
00889024263963	K982981	000
00889024263956	K982981	000
00889024263949	K982981	000
00889024263932	K982981	000
00889024263925	K982981	000
00889024632943	K982981	000