FDA Registration
Active
🇺🇸 United States
FLEX-CELL PRECISION, INC.
Reg #: 3010120135
·
FEI: 3010120135
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
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
- K213842
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-01-17 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-01-17 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-01-17 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)