FDA 510(k) Application Details - K993975

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K993975
Device Name	Screw, Fixation, Bone
Applicant	INNOVASIVE DEVICES, INC. 734 FOREST ST. MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	KATHLEEN MORAHAN Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1999
Decision Date	12/20/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review