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FDA 510(k)

Valkyrie Thoracic Fixation System

K-Number: K211695 · 2021-06-23

ApplicantJm Longyear Manufacturing, LLC D/B/A Able Medical Devices
Decision Date2021-06-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2021-06-23 under approval number K211695. 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 Valkyrie Thoracic Fixation System?

Valkyrie Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. The 510(k) number is K211695.

When was Valkyrie Thoracic Fixation System approved by the FDA?

Valkyrie Thoracic Fixation System received FDA 510(k) clearance on 2021-06-23, under approval number K211695.

What company makes Valkyrie Thoracic Fixation System?

Valkyrie Thoracic Fixation System is manufactured by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices.

What is the FDA product code for Valkyrie Thoracic Fixation System?

The FDA product code for Valkyrie Thoracic Fixation System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Other Devices by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

K232515Valkyrie Thoracic Fixation System

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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.

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