FDA 510(k) Application Details - K021275

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K021275
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	MICOMED ORTHO GMBH 22086 ELSBERRY WAY LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	CORRINE M TAFLINGER Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2002
Decision Date	07/18/2002
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