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510(k) K061880

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC by Isotis NV — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2007
Date Received
July 3, 2006
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 Isotis NV

  • K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (March 29, 2006)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)
  • K031813 — OSSATURA DENTAL (August 20, 2004)
  • K041344 — OPEN BORE SYRINGE (July 16, 2004)
  • K030131 — OSSATURA BCP BONE VOID FILLER (May 20, 2003)
  • K010840 — SYNPLUG (April 20, 2001)
  • K000587 — SHUTTLE STOP (May 4, 2000)

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