FDA Registration
Active
🇺🇸 United States
Hinged ROM Elbow Brace - 3D2320/3D2330
Reg #: 3013410870
·
FEI: 3013410870
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTHOZA
- Registration Number
- 3013410870
- FEI Number
- 3013410870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 57 CHURCH ST
- City
- Freeport
- State
- NY
- ZIP
- 11520
- Country
- US
Owner / Operator
- Firm Name
- 3D ORTHO LLC ORTHOZA
- Operator Number
- 10053743
- Address
- 6320 AUSTIN ST
- City
- Rego Park
- State
- NY
- Postal Code
- 11374
- Country
- US
- Correspondent
- PINKHAS KALANTAROV
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2025-02-24 |
Proprietary Names
Hinged ROM Elbow Brace - 3D2320/3D2330
Comfortland Suspension Sleeve - 3D007
Universal Shoulder Immobilizer - 3D2800
Comfortmax Shoulder/Arm Abduction System - 3D800
Iso Preferred Airplane Shoulder Brace with Abduction - 3D400
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility