Cleared Traditional

Alians Fragment Specific

K170843 · Newclip Technics · Orthopedic
Jun 2017
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K170843 is an FDA 510(k) clearance for the Alians Fragment Specific, 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 June 16, 2017, 87 days after receiving the submission on March 21, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K170843 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2017
Decision Date June 16, 2017
Days to Decision 87 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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