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510(k) K191764

Inion BioRestore by Inion OY — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2019
Date Received
July 1, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
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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