Cleared Special

Medline UNITE? REFLEX? Nitinol Staple Kit

K232905 · Medline Industries, LP · Orthopedic
Oct 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232905 is an FDA 510(k) clearance for the Medline UNITE? REFLEX? Nitinol Staple Kit, 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 October 19, 2023, 30 days after receiving the submission on September 19, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K232905 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2023
Decision Date October 19, 2023
Days to Decision 30 days
Submission Type Special
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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