POROUS TITANIUM ACETABULAR AUGMENTS

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 Porous Titanium Acetabular Augments.

Device ID	K052888
510k Number	K052888
Device Name:	POROUS TITANIUM ACETABULAR AUGMENTS
Classification	Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant	BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
Contact	Allison Koskey
Correspondent	Allison Koskey BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587
Product Code	KWA
Subsequent Product Code	JDI
Subsequent Product Code	JDL
Subsequent Product Code	KWZ
Subsequent Product Code	LPH
Subsequent Product Code	LZO
Subsequent Product Code	MAY
Subsequent Product Code	MEH
CFR Regulation Number	888.3330 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2005-10-13
Decision Date	2005-12-06
Summary:	summary