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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
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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
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