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510(k) K121313

MTF NEW BONE VOID FILLER by Musculoskeletal Transplant Foundation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2013
Date Received
May 2, 2012
Clearance Type
Traditional
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 Musculoskeletal Transplant Foundation

  • K181633 — MTF Pre-Sutured Tendon (March 15, 2019)
  • K120479 — MTF FASCIA (November 8, 2012)
  • K113167 — MTF NEW BONE VOILD FILLER (January 24, 2012)
  • K110003 — MTF NEW BONE VOID FILLER (October 13, 2011)
  • K103784 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY (October 2, 2009)
  • K091218 — DBX DEMINERALIZED BONE MATRIX PUTTY (September 28, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)
  • K080405 — SYGNAL DBM (August 28, 2008)

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  • K251556 — Device 300423 Granules (July 17, 2025)
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  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)