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510(k) K151360

Inion Spinal Graft Containment System by Inion OY — Product Code OJB

Clearance Details

Decision
SESU ()
Decision Date
October 6, 2015
Date Received
May 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.

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  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
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Other clearances for product code OJB

  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)
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