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510(k) K051821

Device
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
Applicant
INION LTD.
510(k) number
K051821
Product code
OJB  
Decision
Substantially Equivalent (SESE)
Decision date
2005-11-25
Date received
2005-07-05
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
HANNA MARTTILA
Address
Laakarinkatu 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
K151360Inion Spinal Graft Containment SystemInion OY2015-10-06
K071810INION SPINAL GRAFT CONTAINMENT SYSTEMInion , Ltd.2008-07-11

Legacy Summary#

summary

FDA Review#

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