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510(k) K243949

OsteoFlo HydroFiber by SurGenTec, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2025
Date Received
December 23, 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 SurGenTec, LLC

  • K251714 — Ion-C (January 16, 2026)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)
  • K243580 — GraftGun Universal Graft Delivery System (GDS) (February 5, 2025)
  • K243835 — TiLink-P SI Joint Fusion System (December 27, 2024)
  • K242797 — OsteoFlo HydroFiber (December 23, 2024)
  • K243265 — Ion 3D (December 4, 2024)
  • K242414 — TiLink-P Joint Fusion System (November 21, 2024)
  • K242141 — TiLink-P SI Joint Fusion System (August 21, 2024)
  • K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (August 9, 2024)

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)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)
  • K250521 — NanoBone® SBX Putty ; NanoBone® QD (April 7, 2025)