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510(k) K192674

Mixing and Delivery System by Bone Solutions, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Bone Solutions, Inc.

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  • K234013 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (February 5, 2024)
  • K221256 — Mg OSTEOINJECT (June 28, 2022)
  • K212991 — Osteorevive (January 21, 2022)
  • K161568 — Bone Solutions Mixing and Delivery System (September 16, 2016)
  • K071004 — OSTEOCRETE BONE VOID FILLER (May 21, 2009)

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