Cleared Traditional

OsteoFlo? HydroPutty?

K231716 · SurGenTec, LLC · Orthopedic
Oct 2023
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K231716 is an FDA 510(k) clearance for the OsteoFlo? HydroPutty?, 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 October 2, 2023, 111 days after receiving the submission on June 13, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231716 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2023
Decision Date October 02, 2023
Days to Decision 111 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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