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510(k) K042072

CALLOS CMF BONE VOID FILLER by Skeletal Kinetics, LLC — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2004
Date Received
August 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
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)
  • K111538 — SKAFFOLD CIS (October 25, 2011)
  • 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)
  • K030554 — CALLOS (May 20, 2003)

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  • K221933 — MONTAGE Settable, Resorbable Bone Putty (January 13, 2023)
  • K182742 — DB-CMF (June 20, 2019)
  • K162864 — OsteoVation Impact (January 13, 2017)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)