Data / Medical devices / United States / Able Medical Devices
Able Medical Devices: FDA-registered device maker in Marquette, MI, United States, 3 510(k) clearances
Able Medical Devices is registered with the FDA (registration 3038776593) in Marquette, MI, United States. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3038776593
- Address
- 2812 Beecher Street, Marquette, MI, United States, 49855
- Owner or operator
- J.M. Longyear Manufacturing, LLC d/b/a Able Medical Devices (10058122)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 18, 2019
- Registered through
- 2026
- Brand names listed
- Valkyrie Rib Thoracic Fixation System, Valkyrie Thoracic Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 8, 2023 | K232515 | Valkyrie Thoracic Fixation System | HRS | Substantially Equivalent | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | accessdata.fda.gov |
| June 23, 2021 | K211695 | Valkyrie Thoracic Fixation System | HRS | Substantially Equivalent | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | accessdata.fda.gov |
| March 2, 2021 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | HRS | Substantially Equivalent | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor
- All makers of Guide, Drill, Ligament
- All makers of Bit, Drill
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
Updated December 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.