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510(k) K153608

Vitoss BiModal Bone Graft Substitute Foam Strip by Orthovita, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2016
Date Received
December 17, 2015
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

Other clearances by Orthovita, Inc.

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  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K103173 — VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE (February 7, 2011)
  • K101171 — ORTHOVITA PEEK SPACER (January 25, 2011)
  • K102545 — FM-02 BONE GRAFT SUBSTITUTE (October 27, 2010)
  • K091618 — VITOMATRIX (September 27, 2010)
  • K080108 — CORTOSS BONE AUGMENTATION MATERIAL (June 5, 2009)

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