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510(k) K243474

MagnetOs MIS by Kuros Biosciences B.V — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2025
Date Received
November 8, 2024
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 Kuros Biosciences B.V

  • K241212 — MagnetOs Easypack Putty (June 27, 2024)
  • K240442 — MagnetOs Putty (April 1, 2024)
  • K232347 — MagnetOs Granules (January 19, 2024)
  • K230736 — MagnetOs Putty (December 20, 2023)
  • K233607 — MagnetOs Easypack Putty (December 15, 2023)
  • K233245 — MagnetOs Flex Matrix (November 21, 2023)
  • K213959 — MagnetOs Flex Matrix (April 14, 2022)
  • K213111 — MagnetOs granules (January 10, 2022)
  • K211201 — MagnetOs Easypack Putty (September 2, 2021)
  • K183092 — Kuros TLIF Cage (March 8, 2019)

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)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)
  • K250521 — NanoBone® SBX Putty ; NanoBone® QD (April 7, 2025)