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Valkyrie Thoracic Fixation System

by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices 2 variants

510(k) K211695

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK211695 Date23 Jun 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Valkyrie Thoracic Fixation System is a device intended for the stabilization and fixation of thoracic spinal segments. It is designed to provide internal fixation for the treatment of thoracic spine injuries or deformities.

The system is supplied as a non-sterile, reusable surgical instrument set. It is intended for use in a hospital operating room setting by trained medical professionals. The device received FDA 510(k) clearance (K211695) and is classified under product code HRS with orthopedic advisory committee review.

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

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Valkyrie Thoracic Fixation System used for?

    The Valkyrie Thoracic Fixation System is intended for the stabilization and fixation of thoracic spinal segments, providing internal fixation for the treatment of thoracic spine injuries or deformities in a hospital operating room setting by trained medical professionals.

  • Is the Valkyrie Thoracic Fixation System sterile or non-sterile, and is it reusable?

    The system is supplied as a non-sterile, reusable surgical instrument set, meaning it must be sterilized by the user before each use and can be reprocessed and reused multiple times following appropriate cleaning and sterilization protocols.

  • What regulatory pathway was used for the Valkyrie Thoracic Fixation System?

    The device received FDA 510(k) clearance under submission number K211695, indicating it was found substantially equivalent to a legally marketed predicate device, and was reviewed by the Orthopedic advisory committee under product code HRS.