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510(k) K151360

Device
Inion Spinal Graft Containment System
Applicant
Inion Oy
510(k) number
K151360
Product code
OJB  
Decision
Se - With Limitations (SESU)
Decision date
2015-10-06
Date received
2015-05-20
Regulation
888.3060
Classification name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kati Marttinen
Address
Lääkärinkatu 2 Tampere FI 33520 33520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071810INION SPINAL GRAFT CONTAINMENT SYSTEMInion , Ltd.2008-07-11
K051821INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMInion , Ltd.2005-11-25

Legacy Summary#

summary

FDA Review#

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