FDA Registration
Active
🇺🇸 United States
Able Medical Devices
Reg #: 3038776593
·
FEI: 3038776593
·
Expires 2026
Products
11
Proprietary Names
2
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Able Medical Devices
- Registration Number
- 3038776593
- FEI Number
- 3038776593
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2812 Beecher Street
- City
- Marquette
- State
- MI
- ZIP
- 49855
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211695
Owner / Operator
- Firm Name
- Able Medical Devices
- Operator Number
- 10058122
- Address
- 512 Fourth Street
- City
- Gwinn
- State
- MI
- Postal Code
- 49841
- Country
- US
- Correspondent
- Halie Gibson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-09-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-09-22 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2025-12-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-03-18 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-03-18 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2023-12-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-11-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-12-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-03-18 |
Proprietary Names
Valkyrie Rib Thoracic Fixation System
Valkyrie Thoracic Fixation System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)