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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 the device name listed in this FDA 510(k) record. The listed applicant is Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. It received FDA 510(k) clearance on 2021-06-23 under 510(k) 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. The listed applicant is Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. The 510(k) number is K211695.

When did Valkyrie Thoracic Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Valkyrie Thoracic Fixation System?

The FDA 510(k) record lists Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232515Valkyrie Thoracic Fixation SystemK202889Able Medical Devices Valkyrie Thoracic Fixation System

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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