FDA Registration
Active
🇺🇸 United States
ScrewFlex
Reg #: 2249418
·
FEI: 2183899
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
- Registration Number
- 2249418
- FEI Number
- 2183899
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8300 Sheen Drive
- City
- St Petersburg
- State
- FL
- ZIP
- 33709
- Country
- US
Owner / Operator
- Firm Name
- S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
- Operator Number
- 9035854
- Address
- 8300 Sheen Drive, --
- City
- St Petersburg
- State
- FL
- Postal Code
- 33709
- Country
- US
- Correspondent
- Subra Naglapura
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-25 |
Proprietary Names
ScrewFlex
Broken and Stripped Screw (S9ScrewFlex)
Removal System, Spine, Legacy (MKS1031)
Removal System, Helicopter Socket Set for Spine (S9COPTER)
Removal System, Spine, Cervical and Instrument Tray V4 (S9SPINE-C)
Xtract-All Spine Helicopter Socket Set
Removal System, Spine, Cervical, Thoracic Lumbar and Instrument Tray V4 (S9SPINE)
Removal System, Spine, Cervical, Thoracic Lumbar and TWO Instrument Trays V4 (S9SPINE-PLUS)
Removal System, Spine, Thoracic Lumbar and Instrument Tray V4 (S9SPINE-TL)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)