FDA 510(k) Application Details - K972791

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented   More FDA Info for this Device
510(K) Number	K972791
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant	ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	ASHLEY M BOCK Other 510(k) Applications for this Contact
Regulation Number	888.3350   More FDA Info for this Regulation Number
Classification Product Code	JDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/1997
Decision Date	01/12/1998
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review