Cleared Traditional

IntraLock Lapidus System

K182342 · Fusion Orthopedics, LLC · Orthopedic
May 2019
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K182342 is an FDA 510(k) clearance for the IntraLock Lapidus 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 May 21, 2019, 266 days after receiving the submission on August 28, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K182342 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2018
Decision Date May 21, 2019
Days to Decision 266 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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