Cleared Traditional

Activmotion S

K241539 · Newclip Technics · Orthopedic
Jul 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K241539 is an FDA 510(k) clearance for the Activmotion S, 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 July 30, 2024, 60 days after receiving the submission on May 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241539 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date July 30, 2024
Days to Decision 60 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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