Cleared Traditional

Foot and Hand Motion

K170012 · Newclip Technics · Orthopedic
Apr 2017
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K170012 is an FDA 510(k) clearance for the Foot and Hand Motion, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on April 24, 2017, 111 days after receiving the submission on January 3, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K170012 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2017
Decision Date April 24, 2017
Days to Decision 111 days
Submission Type Traditional
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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