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510(k) K103173

VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE by Orthovita, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2011
Date Received
October 28, 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

Other clearances by Orthovita, Inc.

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  • K161447 — HydroSet XT (October 6, 2016)
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  • K153306 — Imbibe Needle (December 18, 2015)
  • K140868 — STRYKER KWIC NEEDLE (June 5, 2014)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • 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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