Cleared Traditional

NanoBone? SBX Putty ; NanoBone? QD

K250521 · Biocomposites, Ltd. · Orthopedic
Apr 2025
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K250521 is an FDA 510(k) clearance for the NanoBone? SBX Putty ; NanoBone? QD, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on April 7, 2025, 45 days after receiving the submission on February 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K250521 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date April 07, 2025
Days to Decision 45 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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