Cleared Traditional

Medline UNITE REFLEX Nitinol Staple System

K210482 · Medline Industries, Inc. · Orthopedic
Apr 2021
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K210482 is an FDA 510(k) clearance for the Medline UNITE REFLEX Nitinol Staple System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on April 22, 2021, 62 days after receiving the submission on February 19, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K210482 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2021
Decision Date April 22, 2021
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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