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510(k) K102545

FM-02 BONE GRAFT SUBSTITUTE by Orthovita, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2010
Date Received
September 3, 2010
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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  • K091618 — VITOMATRIX (September 27, 2010)
  • K080108 — CORTOSS BONE AUGMENTATION MATERIAL (June 5, 2009)

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