Cleared Traditional

WIN Flexible Nail System

K193533 · Biomet, Inc. · Orthopedic
Feb 2020
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K193533 is an FDA 510(k) clearance for the WIN Flexible Nail System, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 20, 2020, 62 days after receiving the submission on December 20, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K193533 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2019
Decision Date February 20, 2020
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDS — Nail, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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