Cleared Special

Medline UNITE? Digital Fusion Screw System

K211944 · Medline Industries, Inc. · Orthopedic
Jul 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K211944 is an FDA 510(k) clearance for the Medline UNITE? Digital Fusion Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on July 22, 2021, 29 days after receiving the submission on June 23, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211944 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2021
Decision Date July 22, 2021
Days to Decision 29 days
Submission Type Special
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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