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510(k) K120354

BETA-TCP GRANULES by Skeletal Kinetics, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2013
Date Received
February 6, 2012
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 Skeletal Kinetics, LLC

  • K162864 — OsteoVation Impact (January 13, 2017)
  • K132211 — SKAFFOLD NMX BONE VOID FILLER (August 4, 2014)
  • 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)
  • K042072 — CALLOS CMF BONE VOID FILLER (September 16, 2004)
  • K030554 — CALLOS (May 20, 2003)

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