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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
510(k) Number K151360
Device Name Inion Spinal Graft Containment System
Applicant
Inion OY
Lääkärinkatu 2
Tampere,  FI 33520
Applicant Contact Kati Marttinen
Correspondent
Inion OY
Lääkärinkatu 2
Tampere,  FI 33520
Correspondent Contact Kati Marttinen
Regulation Number888.3060
Classification Product Code
OJB  
Date Received05/20/2015
Decision Date 10/06/2015
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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