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510(k) K123672

INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) by Inion OY — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2013
Date Received
November 29, 2012
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

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  • K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (February 20, 2009)
  • K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM (July 11, 2008)
  • K070998 — INION BIORESTORE (October 11, 2007)

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