FDA Registration
Active
🇺🇸 United States
Triathlon PKR System
Reg #: 3017410889
·
FEI: 3005985723
·
Expires 2025
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- MAKO SURGICAL CORP.
- Registration Number
- 3017410889
- FEI Number
- 3005985723
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3365 ENTERPRISE AVE
- City
- Weston
- State
- FL
- ZIP
- 33331
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242831
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2025-02-28 |
Proprietary Names
Triathlon PKR System
Restoris MCK Knee System
Triathlon Knee System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility