Cleared Traditional

Impact PEEK Union Nail System

K250646 · Nvision Biomedical Technologies · Orthopedic
Jun 2025
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K250646 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 (San Antonio, US). The FDA issued a Cleared decision on June 11, 2025, 99 days after receiving the submission on March 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250646 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2025
Decision Date June 11, 2025
Days to Decision 99 days
Submission Type Traditional
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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