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510(k) K111538

SKAFFOLD CIS by Skeletal Kinetics, LLC — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2011
Date Received
June 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Skeletal Kinetics, LLC

  • K162864 — OsteoVation Impact (January 13, 2017)
  • K132211 — SKAFFOLD NMX BONE VOID FILLER (August 4, 2014)
  • K120354 — BETA-TCP GRANULES (March 21, 2013)
  • K112383 — CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER (February 7, 2012)
  • K100986 — CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION (July 20, 2010)
  • K051784 — OSTEOVATION CMF BONE VOID FILLER (July 20, 2005)
  • K051123 — CALLOS IMPACT AND INJECT BONE VOID FILLER (June 3, 2005)
  • K042072 — CALLOS CMF BONE VOID FILLER (September 16, 2004)
  • K030554 — CALLOS (May 20, 2003)

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  • K153317 — HEMASORBPLUS Resorbable Hemostatic Bone Putty (November 30, 2016)
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