Cleared Traditional

Fusion Silastic System

K190136 · Fusion Orthopedics, LLC · Orthopedic
Oct 2019
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K190136 is an FDA 510(k) clearance for the Fusion Silastic System, a Prosthesis, Toe, Constrained, Polymer (Class II — Special Controls, product code KWH), submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on October 21, 2019, 265 days after receiving the submission on January 29, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3720.

Submission Details

510(k) Number K190136 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2019
Decision Date October 21, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWH — Prosthesis, Toe, Constrained, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3720

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