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510(k) K090855

EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE by Etex Corp. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2009
Date Received
March 30, 2009
Clearance Type
Traditional
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)
  • 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)
  • 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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  • K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix (September 30, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
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  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
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  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)