Cleared Traditional

Steinmann Pins and Kirschner Wires

K211508 · Stryker GmbH · Orthopedic
Oct 2021
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K211508 is an FDA 510(k) clearance for the Steinmann Pins and Kirschner Wires, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on October 5, 2021, 144 days after receiving the submission on May 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211508 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2021
Decision Date October 05, 2021
Days to Decision 144 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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