FDA 510(k) Application Details - K001044

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K001044
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	ACME SPINE, LLC. 9980 INDIANA AVE. UNIT 9 RIVERSIDE, CA 92503 US Other 510(k) Applications for this Company
Contact	TIMOTHY WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2000
Decision Date	11/03/2000
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