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510(k) K251522

Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ by Bone Solutions, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2025
Date Received
May 16, 2025
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.

  • K242372 — Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (October 18, 2024)
  • K234013 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (February 5, 2024)
  • K221256 — Mg OSTEOINJECT (June 28, 2022)
  • 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)

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