Cleared Traditional

Activmotion Range

K173746 · Newclip Technics · Orthopedic
Feb 2018
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K173746 is an FDA 510(k) clearance for the Activmotion Range, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on February 27, 2018, 81 days after receiving the submission on December 8, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K173746 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2017
Decision Date February 27, 2018
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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