Cleared Traditional

Medline UNITE? Medial Malleolus Peg Plate System

K221360 · Medline Industries, LP · Orthopedic
Sep 2022
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K221360 is an FDA 510(k) clearance for the Medline UNITE? Medial Malleolus Peg Plate System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on September 27, 2022, 139 days after receiving the submission on May 11, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221360 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2022
Decision Date September 27, 2022
Days to Decision 139 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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