FDA Registration
Active
🇺🇸 United States
ALM ORTHO, INC.
Reg #: 3029890418
·
FEI: 3029890418
·
Expires 2026
Products
7
Proprietary Names
2
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- ALM ORTHO, INC.
- Registration Number
- 3029890418
- FEI Number
- 3029890418
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 68 Mussey Rd
- City
- Scarborough
- State
- ME
- ZIP
- 04074
- Country
- US
Owner / Operator
- Firm Name
- ALM Ortho, Inc.
- Operator Number
- 10079123
- Address
- 68 Mussey Rd
- City
- Scarborough
- State
- ME
- Postal Code
- 04074
- Country
- US
- Correspondent
- Joseph Azary
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2025-08-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-04-15 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2025-04-15 |
| Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | PJY | Class 3 | Unknown | No | 2025-04-15 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 2025-08-21 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2025-02-05 |
| Ankle Fusion Cage | SAI | Class 2 | Orthopedic | No | 2025-04-15 |
Proprietary Names
ALM Anchor Bushing
ALM Anchor Tibial Connector
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only