FDA Registration
Active
🇺🇸 United States
FLEX-CELL PRECISION, INC.
Reg #: 3010120135
·
FEI: 3010120135
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- FLEX-CELL PRECISION, INC.
- Registration Number
- 3010120135
- FEI Number
- 3010120135
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1151 S Duke St
- City
- Lancaster
- State
- PA
- ZIP
- 17602
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111449
Owner / Operator
- Firm Name
- Flex-Cell Precision, Inc.
- Operator Number
- 10043308
- Address
- 1151 South Duke Street
- City
- Lancaster
- State
- PA
- Postal Code
- 17602
- Country
- US
- Correspondent
- Anthony Fanning
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-04 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-04 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)