510(k) Report

FDA applicant

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

Gwinn, MI2 decisions2021–20230 recalls

FDA records 2 decisions for Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices (Gwinn, MI) from 2021 to 2023: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12023: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jm Longyear Manufacturing, LLC D/B/A…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HRSPlate, Fixation, Bone2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices · 20211cites it

What has FDA decided for it lately?

  • K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices · 2023
  • K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices · 2021

All 2 as Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices →