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510(k) K091193

ACCELL EVO3C by Isotis Orthobiologics, Inc. — Product Code MBP

K091193 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "ACCELL EVO3C". The FDA issued a decision of Substantially Equivalent on August 10, 2009. 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. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2009
Date Received
April 23, 2009
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 Isotis Orthobiologics, Inc.

  • K081817 — ACCELL TBM-R (September 24, 2008)
  • K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (October 15, 2007)
  • K050642 — ORTHOBLAST II PUTTY AND PASTE (December 5, 2005)
  • K052098 — CONNEXUS, .5CC, MODEL 023000-005 (September 7, 2005)
  • K043573 — DYNAGRAFT II DENTAL (July 29, 2005)
  • K050690 — CONNEXUS (July 7, 2005)
  • K040419 — DYNAGRAFT II (March 25, 2005)
  • K042706 — OSSATURA DENTAL (October 20, 2004)
  • K041991 — ASPIREX - BONE MARROW ASPIRATE KIT (September 16, 2004)

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)
  • 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