FDA 510(k) Application Details - K151360

Device Classification Name	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate   More FDA Info for this Device
510(K) Number	K151360
Device Name	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Applicant	Inion Oy LΣΣkΣrinkatu 2 Tampere 33520 FI Other 510(k) Applications for this Company
Contact	Kati Marttinen Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	OJB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2015
Decision Date	10/06/2015
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review