Cleared Special

ToeMATE? Hammertoe Correction System

K170350 · Arthrosurface, Inc. · Orthopedic
Mar 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K170350 is an FDA 510(k) clearance for the ToeMATE? Hammertoe Correction System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on March 3, 2017, 28 days after receiving the submission on February 3, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K170350 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2017
Decision Date March 03, 2017
Days to Decision 28 days
Submission Type Special
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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