FDA Registration
Active
🇺🇸 United States
NIDO Tray, 2" Base
Reg #: 3009165919
·
FEI: 3009165919
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Kalitec Direct LLC DBA Kalitec Medical
- Registration Number
- 3009165919
- FEI Number
- 3009165919
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 865 Oviedo Blvd, Suite 1017
- City
- Oviedo
- State
- FL
- ZIP
- 32765
- Country
- US
Owner / Operator
- Firm Name
- Kalitec Medical
- Operator Number
- 10037099
- Address
- 865 Oviedo Blvd, Suite 1017
- City
- Oviedo
- State
- FL
- Postal Code
- 32765
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2018-06-21 |
Proprietary Names
NIDO Tray, 2" Base
NIDO Tray, 4.25" Base
NIDO Tray Insert 2 (FROM COSMO)
NIDO Caddie, Domino Connectors
NIDO Caddie, Tulip Connectors
NIDO Caddie Lid, Modular Bone Screws
NIDO Tray Insert 1
NIDO Tray Insert 4
NIDO Caddie, Locking Caps
NIDO Rod Connector Tray Insert 1
NIDO Caddie,Modular Bone Screws
NIDO Tray Insert 3
NIDO Implant Tray 1, Degen
NIDO Caddie,Locking Caps
NIDO Caddie Lid, Modular Heads, Polyaxial
NIDO Caddie Lid, Tulip and Domino Connectors
NIDO Caddie, Modular Heads, Polyaxial
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198