ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

ZIMMER, INC.

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

Pre-market Notification Details

• Device ID: K130661
• 510k Number: K130661
• Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Anthony Francalancia
• Correspondent: Anthony Francalancia; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-12
• Decision Date: 2013-05-09
• Summary: summary