Cleared Special

Impact PEEK Union Nail System

K252657 · Nvision Biomedical Technologies, Inc. · Orthopedic
Sep 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K252657 is an FDA 510(k) clearance for the Impact PEEK Union Nail System, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 19, 2025, 28 days after receiving the submission on August 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252657 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2025
Decision Date September 19, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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