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510(k) K130498

OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY by Bacterin International, Inc. — Product Code MBP

K130498 is an FDA 510(k) premarket notification submitted by Bacterin International, Inc. for the device "OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY". The FDA issued a decision of Substantially Equivalent on May 31, 2013. 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. Bacterin International, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
February 26, 2013
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 Bacterin International, Inc.

  • K150621 — OsteoSelect PLUS Demineralized Bone Matrix Putty (August 18, 2015)
  • K091321 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (September 11, 2009)
  • K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (November 28, 2007)

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)
  • 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)
  • K080405 — SYGNAL DBM (August 28, 2008)

FDA data resources