Cleared Traditional

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

K180580 · Surgical Instrument Service and Savings, Inc. · Orthopedic
Jul 2018
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K180580 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on July 27, 2018, 144 days after receiving the submission on March 5, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K180580 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2018
Decision Date July 27, 2018
Days to Decision 144 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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