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

- Location (FDA's records): Gwinn, MI
- FDA decisions: 2 (2021–2023): 2 510(k) clearances
- Product codes: HRS (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices: 2 (https://510kreport.com/company/jm-longyear-manufacturing-dba-able-medical-devices)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)

## Its most-cited devices
- K211695: Valkyrie Thoracic Fixation System (2021), cited by 1

## Recent decisions
- K232515: Valkyrie Thoracic Fixation System (Dec 8, 2023)
- K211695: Valkyrie Thoracic Fixation System (Jun 23, 2021)

Source page: https://510kreport.com/company/jm-longyear-manufacturing-d-b-a-able-medical-devices