FDA Registration
Active
🇺🇸 United States
SEG TIB TISSUE ATTACH PROV RIGHT
Reg #: 3011015572
·
FEI: 3011015572
·
Expires 2025
Products
1
Proprietary Names
5
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
- K110940
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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-11-20 |
Proprietary Names
SEG TIB TISSUE ATTACH PROV RIGHT
PROXIMAL FEMUR TEMPLATE 38MM
SEG TIB TISSUE ATTACH PROV LEFT
PROXIMAL FEMUR TEMPLATE 46MM
SEG PROX TIB TISSUE ATTACH KIT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)