ANATOMICAL SHOULDER INVERSE/REVERSE

Shoulder Prosthesis, Reverse Configuration

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Anatomical Shoulder Inverse/reverse.

Device ID	K053274
510k Number	K053274
Device Name:	ANATOMICAL SHOULDER INVERSE/REVERSE
Classification	Shoulder Prosthesis, Reverse Configuration
Applicant	ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708
Contact	Dalene T Binkley
Correspondent	Dalene T Binkley ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708
Product Code	PHX
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	2005-11-23
Decision Date	2006-01-25
Summary:	summary