Cleared Traditional

Large Screws Range

K160617 · Newclip Technics · Orthopedic
Jun 2016
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K160617 is an FDA 510(k) clearance for the Large Screws Range, 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 June 3, 2016, 92 days after receiving the submission on March 3, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K160617 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2016
Decision Date June 03, 2016
Days to Decision 92 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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