CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Cls Brevius Stem With Kinectiv Technology.

Device ID	K110836
510k Number	K110836
Device Name:	CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
Classification	Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant	ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708
Contact	Daniel J Williman
Correspondent	Daniel J Williman ZIMMER GMBH P.O. BOX 708 Warsaw, IN 46581 -0708
Product Code	KWA
Subsequent Product Code	JDI
Subsequent Product Code	JDL
Subsequent Product Code	KWZ
Subsequent Product Code	LPH
Subsequent Product Code	LWJ
Subsequent Product Code	LZO
CFR Regulation Number	888.3330 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2011-03-25
Decision Date	2011-10-07
Summary:	summary