Cleared Traditional

Medline UNITE? REFLEX? Nitinol Staple System

K231885 · Medline Industries, LP · Orthopedic
Aug 2023
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K231885 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, LP (Nortfield, US). The FDA issued a Cleared decision on August 9, 2023, 43 days after receiving the submission on June 27, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K231885 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2023
Decision Date August 09, 2023
Days to Decision 43 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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