Cleared Special

OsteoFlo HydroFiber

K251720 · SurGenTec, LLC · Orthopedic
Jul 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251720 is an FDA 510(k) clearance for the OsteoFlo HydroFiber, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 2, 2025, 28 days after receiving the submission on June 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K251720 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2025
Decision Date July 02, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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