FDA Registration
Active
🇺🇸 United States
FEMORAL PROVISIONAL INSERTER
Reg #: 3011015572
·
FEI: 3011015572
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INCIPIO DEVICES
- Registration Number
- 3011015572
- FEI Number
- 3011015572
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3650 West 200 North
- City
- Huntington
- State
- IN
- ZIP
- 46750
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031061
Owner / Operator
- Firm Name
- Incipio Devices
- Operator Number
- 10047511
- Address
- 3650 W 200 N
- City
- Huntington
- State
- IN
- Postal Code
- 46750
- Country
- US
- Correspondent
- Troy Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2017-11-20 |
Proprietary Names
FEMORAL PROVISIONAL INSERTER
PG HL DRILL GDE HANDLE ASSY
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)