FDA Registration
Active
🇺🇸 United States
Thoracolumbosacral pedicle screw system
Reg #: 3010128826
·
FEI: 3010128826
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LS INVESTMENT II
- Registration Number
- 3010128826
- FEI Number
- 3010128826
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 38205 Western Pkwy
- City
- Willoughby
- State
- OH
- ZIP
- 44094
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142576
Owner / Operator
- Firm Name
- LS INVESTMENT II LLC DBA PM MACHINE
- Operator Number
- 10043543
- Address
- 38205 Western Pkwy
- City
- Willoughby
- State
- OH
- Postal Code
- 44094
- Country
- US
- Correspondent
- Jeff Newmark
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-10-21 |
Proprietary Names
Thoracolumbosacral pedicle screw system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)