Cleared Traditional

Medline ReNewal Reprocessed Stryker External Fixation Devices

K163028 · Surgical Instrument Service and Savings, Inc. · Orthopedic
Dec 2016
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K163028 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Stryker External Fixation Devices, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 28, 2016, 58 days after receiving the submission on October 31, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K163028 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2016
Decision Date December 28, 2016
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JEC — Component, Traction, Invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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