Home / 510(k) Clearances / K103742

510(k) K103742

ACCELL EVO3 (FORMERLY ACCELL A2I) by Integra Life Sciences — Product Code MBP

K103742 is an FDA 510(k) premarket notification submitted by Integra Life Sciences for the device "ACCELL EVO3 (FORMERLY ACCELL A2I)". The FDA issued a decision of Substantially Equivalent on March 17, 2011. 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. Integra Life Sciences has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2011
Date Received
December 23, 2010
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 Integra Life Sciences

  • K120600 — DURAGEN SECURE DURAL REGNERATION MATRIX (June 15, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)

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)
  • 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