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510(k) K101557

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN by Etex Corp. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2010
Date Received
June 4, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Etex Corp.

  • K100883 — CARRIGEN (December 21, 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)
  • K080329 — CAP PLUS, EQUIVABONE, CAP/DBM (April 28, 2008)
  • K063050 — CAP PLUS (November 19, 2007)
  • K072636 — A-BSM BONE SUBSTITUTE MATERIAL (October 23, 2007)

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