Cleared Traditional

IntraLock System

K210159 · Fusion Orthopedics, LLC · Orthopedic
Jul 2021
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K210159 is an FDA 510(k) clearance for the IntraLock System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Fusion Orthopedics, LLC (Mesa, US). The FDA issued a Cleared decision on July 23, 2021, 183 days after receiving the submission on January 21, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K210159 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2021
Decision Date July 23, 2021
Days to Decision 183 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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