ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

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

Device ID	K133378
510k Number	K133378
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	Dan Williman
Correspondent	Dan Williman 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
Subsequent Product Code	PAO
CFR Regulation Number	888.3660 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2013-11-04
Decision Date	2014-05-12
Summary:	summary