Cleared Traditional

OsteoFlo HydroFiber

K242797 · SurGenTec, LLC · Orthopedic
Dec 2024
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K242797 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 December 23, 2024, 98 days after receiving the submission on September 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K242797 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2024
Decision Date December 23, 2024
Days to Decision 98 days
Submission Type Traditional
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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