FDA Registration
Active
🇺🇸 United States
3D ORTHO - BLUE BACK BRACE; BB31, BB37
Reg #: 3013410870
·
FEI: 3013410870
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
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 |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2017-08-09 |
Proprietary Names
3D ORTHO - BLUE BACK BRACE; BB31, BB37
3D ORTHO - GALAXY; GL26, GL27, GL30, GL31, GLP31, GL37, GLP37, GL39
3D ORTHO - GRAY BACK BRACE; GB31, GB37
3D ORTHO - WHITE BACK BRACE; WB31, WB37
3D ORTHO - VECTOR; VC26, VC27, VC30, VC31, VCP31, VC37, VCP37, VC39
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device