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510(k) K042829

DBX STRIP by Musculoskeletal Transplant Foundation — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
October 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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)
  • K121313 — MTF NEW BONE VOID FILLER (January 11, 2013)
  • 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)

Other clearances for product code MBP

  • K242799 — PliaFX Flo (November 21, 2024)
  • K143547 — Vivorte Trabexus EB (January 14, 2015)
  • K130703 — VIVORTE BVF (September 12, 2013)
  • K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (May 31, 2013)
  • K122513 — CLEARED UNDER GRAFTON II EDBM (March 6, 2013)
  • K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (November 15, 2012)
  • K103742 — ACCELL EVO3 (FORMERLY ACCELL A2I) (March 17, 2011)
  • K091193 — ACCELL EVO3C (August 10, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)
  • K081817 — ACCELL TBM-R (September 24, 2008)