TAPERLOC COMPLETE, SIZE 5 AND 6

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 Taperloc Complete, Size 5 And 6.

Device ID	K103755
510k Number	K103755
Device Name:	TAPERLOC COMPLETE, SIZE 5 AND 6
Classification	Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant	BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
Contact	Becky Earl
Correspondent	Becky Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
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	2010-12-23
Decision Date	2011-01-21
Summary:	summary