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510(k) K051821

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM by Inion , Ltd. — Product Code OJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2005
Date Received
July 5, 2005
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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  • K191764 — Inion BioRestore (July 31, 2019)
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  • K123672 — INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) (February 27, 2013)
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  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)

Other clearances for product code OJB

  • K151360 — Inion Spinal Graft Containment System (October 6, 2015)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)