Cleared Traditional

Footmotion HammerToe

K172485 · Newclip Technics · Orthopedic
Mar 2018
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K172485 is an FDA 510(k) clearance for the Footmotion HammerToe, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on March 2, 2018, 197 days after receiving the submission on August 17, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K172485 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2017
Decision Date March 02, 2018
Days to Decision 197 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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