Cleared Traditional

Acumed Acutrak 3 Headless Compression Screw System

K230744 · Acumed, LLC · Orthopedic
Jun 2023
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K230744 is an FDA 510(k) clearance for the Acumed Acutrak 3 Headless Compression Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on June 9, 2023, 84 days after receiving the submission on March 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230744 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2023
Decision Date June 09, 2023
Days to Decision 84 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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