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510(k) K221256

Mg OSTEOINJECT by Bone Solutions, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2022
Date Received
May 2, 2022
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 Bone Solutions, Inc.

  • K251522 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (October 13, 2025)
  • K242372 — Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (October 18, 2024)
  • K234013 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (February 5, 2024)
  • K212991 — Osteorevive (January 21, 2022)
  • K192674 — Mixing and Delivery System (February 18, 2020)
  • K161568 — Bone Solutions Mixing and Delivery System (September 16, 2016)
  • K071004 — OSTEOCRETE BONE VOID FILLER (May 21, 2009)

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)