FDA 510(k) Application Details - K974289

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K974289
Device Name	Plate, Fixation, Bone
Applicant	HOWMEDICA, INC. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/1997
Decision Date	02/12/1998
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