FDA Registration
Active
🇺🇸 United States
BKS® Revision Sleeves
Reg #: 1722511
·
FEI: 1000143502
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- ORTHO DEVELOPMENT CORP.
- Registration Number
- 1722511
- FEI Number
- 1000143502
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12187 SOUTH BUSINESS PARK DR.
- City
- DRAPER
- State
- UT
- ZIP
- 84020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181569
Owner / Operator
- Firm Name
- Ortho Development Corporation
- Operator Number
- 9012515
- Address
- 12187 South Business Park Drive, --
- City
- Draper
- State
- UT
- Postal Code
- 84020
- Country
- US
- Correspondent
- Drew Weaver
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 | 2018-10-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-10-15 |
Proprietary Names
BKS® Revision Sleeves
Establishment Types
Manufacture Medical Device