Able Medical Devices Valkyrie Thoracic Fixation System
K-Number: K202889 · 2021-03-02
Decision Date2021-03-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Able Medical Devices Valkyrie Thoracic Fixation System is a medical device manufactured by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. It received FDA 510(k) clearance on 2021-03-02 under approval number K202889. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Able Medical Devices Valkyrie Thoracic Fixation System?
Able Medical Devices Valkyrie Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. The 510(k) number is K202889.
When was Able Medical Devices Valkyrie Thoracic Fixation System approved by the FDA?
Able Medical Devices Valkyrie Thoracic Fixation System received FDA 510(k) clearance on 2021-03-02, under approval number K202889.
What company makes Able Medical Devices Valkyrie Thoracic Fixation System?
Able Medical Devices Valkyrie Thoracic Fixation System is manufactured by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices.
What is the FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System?
The FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System is HRS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.