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510(k) K071464

INION HEXALON BIODEGRADABLE ACL/PCL SCREW by Inion OY — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2007
Date Received
May 29, 2007
Clearance Type
Traditional
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 OY

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  • K123672 — INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) (February 27, 2013)
  • 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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