Cleared Traditional

Medline UNITE REFLEX Dynamic Discs

K211612 · Medline Industries, Inc. · Orthopedic
Dec 2021
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K211612 is an FDA 510(k) clearance for the Medline UNITE REFLEX Dynamic Discs, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on December 10, 2021, 198 days after receiving the submission on May 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K211612 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2021
Decision Date December 10, 2021
Days to Decision 198 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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