Cleared Special

SnapHammer Hammertoe Correction System

K250613 · Nvision Biomedical Technologies, Inc. · Orthopedic
Apr 2025
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K250613 is an FDA 510(k) clearance for the SnapHammer Hammertoe Correction System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 2, 2025, 33 days after receiving the submission on February 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250613 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2025
Decision Date April 02, 2025
Days to Decision 33 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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