Cleared Traditional

Medline UNITE? MIS Foot Recon Screw System

K241359 · Medline Industries, LP · Orthopedic
Aug 2024
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K241359 is an FDA 510(k) clearance for the Medline UNITE? MIS Foot Recon Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on August 2, 2024, 80 days after receiving the submission on May 14, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241359 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2024
Decision Date August 02, 2024
Days to Decision 80 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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