FDA Registration
Active
🇺🇸 United States
Posterior Night Splint - 3D63103
Reg #: 3013410870
·
FEI: 3013410870
·
Expires 2025
Products
1
Proprietary Names
3
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, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-10-25 |
Proprietary Names
Posterior Night Splint - 3D63103
3D ORTHO, ANKLE BRACES, AIRCAST GEL, AIRCAST DELUXE, ANKLE SUPPORT WITH JOINTS, ANKLE SUPPORT PLASTIC PANELS
3D ORTHO PLANTAR FASCIITIS NIGHT SPLINT, 3D ORTHO SILICONE GEL HEEL CUP, 3D ORTHO DORSAL NIGHT SPLINT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility