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510(k) K062617

MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM by Inion , Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2006
Date Received
September 5, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Inion , Ltd.

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  • K122890 — INION CPS ORBITAL PLATES (January 29, 2013)
  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)

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