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510(k) K080329

CAP PLUS, EQUIVABONE, CAP/DBM by Etex Corp. — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2008
Date Received
February 7, 2008
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 Etex Corp.

  • K100883 — CARRIGEN (December 21, 2010)
  • K101557 — GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN (July 1, 2010)
  • K093447 — CARRIGEN (February 18, 2010)
  • K091729 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (December 23, 2009)
  • K091607 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (November 2, 2009)
  • K090855 — EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE (September 18, 2009)
  • K090310 — EQUIVABONE (March 24, 2009)
  • K090242 — GAMMA-BSM, BETA-BSM (February 20, 2009)
  • K063050 — CAP PLUS (November 19, 2007)
  • K072636 — A-BSM BONE SUBSTITUTE MATERIAL (October 23, 2007)

Other clearances for product code MBP

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  • 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)