FDA Registration
Active
🇺🇸 United States
Corin
Reg #: 3012491394
·
FEI: 3012491394
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Summit Orthopedic Technologies Inc.
- Registration Number
- 3012491394
- FEI Number
- 3012491394
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2975 Horseshoe Drive South, Suite 100
- City
- Naples
- State
- FL
- ZIP
- 34104
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102578
Owner / Operator
- Firm Name
- Summit Orthopedic Technologies Inc.
- Operator Number
- 10051828
- Address
- 2975 Horseshoe Drive South, Suite 100
- City
- Naples
- State
- FL
- Postal Code
- 34104
- Country
- US
- Correspondent
- Jason K Blake
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 | 2018-03-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-03-23 |
Proprietary Names
Corin
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)