Able Medical Devices Valkyrie Thoracic Fixation System— 510(k) K202889

Name: FDA 510(k) clearance K202889
Creator: U.S. Food and Drug Administration
Published: 2021-03-02

Substantially Equivalent

Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices

FDA 510(k) clearance K202889 for Able Medical Devices Valkyrie Thoracic Fixation System, Substantially Equivalent on 2021-03-02. Applicant: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. Device class: 2.

Clearance details

Applicant: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-09-28
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwinn, MI, US

Download summary PDF View on FDA.gov ↗

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19

More clearances from Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices

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K232515 — Valkyrie Thoracic Fixation System2023-12-08
K211695 — Valkyrie Thoracic Fixation System2021-06-23

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.