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510(k) K051195

GRAFTON DBM by Osteotech, Inc. — Product Code MBP

K051195 is an FDA 510(k) premarket notification submitted by Osteotech, Inc. for the device "GRAFTON DBM". The FDA issued a decision of Substantially Equivalent on December 16, 2005. 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. Osteotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2005
Date Received
May 10, 2005
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 Osteotech, Inc.

  • K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT (October 16, 2008)
  • K081227 — PLEXUR M (July 22, 2008)
  • K080511 — PLEXUR-P (April 21, 2008)
  • K073405 — PLEXUR M (March 3, 2008)
  • K061982 — PLEXUR P (February 7, 2007)
  • K051188 — GRAFTON DBM (January 3, 2006)
  • K051781 — GRAFTCAGE TLX (December 16, 2005)
  • K043209 — VIAGRAF DBM PASTE (December 5, 2005)
  • K053080 — GRAFTCAGE ACX (December 1, 2005)
  • K042707 — GRAFTON PLUS DBM PASTE (November 30, 2005)

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)

FDA data resources