FDA 510(k) Application Details - K092331

Device Classification Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)   More FDA Info for this Device
510(K) Number	K092331
Device Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	TEFFANY HUTTO Other 510(k) Applications for this Contact
Regulation Number	888.3330   More FDA Info for this Regulation Number
Classification Product Code	KWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	03/03/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review