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510(k) K143547

Vivorte Trabexus EB by Vivorte, Inc. — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2015
Date Received
December 15, 2014
Clearance Type
Special
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 Vivorte, Inc.

  • K143549 — Vivorte Trabexus (January 14, 2015)
  • K130703 — VIVORTE BVF (September 12, 2013)
  • K131133 — VIVORTE BVF LITE (August 12, 2013)

Other clearances for product code MBP

  • K242799 — PliaFX Flo (November 21, 2024)
  • 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)
  • K080405 — SYGNAL DBM (August 28, 2008)