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510(k) K080399

DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE by Musculoskeletal Transplant Foundation — Product Code MBP

K080399 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE". The FDA issued a decision of Substantially Equivalent on October 10, 2008. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Musculoskeletal Transplant Foundation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2008
Date Received
February 14, 2008
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)
  • K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K103784 — 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)
  • K080405 — SYGNAL DBM (August 28, 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)
  • K081817 — ACCELL TBM-R (September 24, 2008)
  • K080405 — SYGNAL DBM (August 28, 2008)

FDA data resources