ALTRA PRESS-FIT HIP SYSTEM

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

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Altra Press-fit Hip System.

Device ID	K063002
510k Number	K063002
Device Name:	ALTRA PRESS-FIT HIP SYSTEM
Classification	Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant	BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582
Contact	Gary Baker
Correspondent	Gary Baker BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582
Product Code	KWA
Subsequent Product Code	JDI
Subsequent Product Code	JDL
Subsequent Product Code	KWL
Subsequent Product Code	KWY
Subsequent Product Code	KWZ
Subsequent Product Code	LPH
Subsequent Product Code	LWJ
Subsequent Product Code	LZO
Subsequent Product Code	MAY
Subsequent Product Code	MEH
CFR Regulation Number	888.3330 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2006-10-02
Decision Date	2006-10-31
Summary:	summary