FDA 510(k) Application Details - K022285

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K022285
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	DEPUY ACROMED 325 PARAMOUNT DR. RAYNHAM, MA 02767-0350 US Other 510(k) Applications for this Company
Contact	LISA GILMAN 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	07/15/2002
Decision Date	08/13/2002
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