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510(k) K061498

ALLOFIX ANCHOR, 5.0 MM ANCHOR by Musculoskeletal Transplant Foundation — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2006
Date Received
May 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K103784 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
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  • K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY (October 2, 2009)
  • K091218 — DBX DEMINERALIZED BONE MATRIX PUTTY (September 28, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)

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