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510(k) K083033

VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE by Orthovita, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2008
Date Received
October 10, 2008
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)
  • K153608 — Vitoss BiModal Bone Graft Substitute Foam Strip (February 12, 2016)
  • K153306 — Imbibe Needle (December 18, 2015)
  • K140868 — STRYKER KWIC NEEDLE (June 5, 2014)
  • 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)

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