Cleared Traditional

Alians Clavicle range

K170310 · Newclip Technics · Orthopedic
Mar 2017
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K170310 is an FDA 510(k) clearance for the Alians Clavicle 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 March 30, 2017, 57 days after receiving the submission on February 1, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K170310 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2017
Decision Date March 30, 2017
Days to Decision 57 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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