Cleared Traditional

SnapHammer Hammertoe Correction System

K231453 · Nvision Biomedical Technologies, Inc. · Orthopedic
Feb 2024
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K231453 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 February 16, 2024, 274 days after receiving the submission on May 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231453 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2023
Decision Date February 16, 2024
Days to Decision 274 days
Submission Type Traditional
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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