Home / 510(k) Clearances / K132211

510(k) K132211

SKAFFOLD NMX BONE VOID FILLER by Skeletal Kinetics, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2014
Date Received
July 16, 2013
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)
  • 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)
  • K042072 — CALLOS CMF BONE VOID FILLER (September 16, 2004)
  • K030554 — CALLOS (May 20, 2003)

Other clearances for product code MQV

  • K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
  • K253147 — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft S (October 22, 2025)
  • K251522 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (October 13, 2025)
  • K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix (September 30, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)