FDA Registration
Active
🇺🇸 United States
Blue Belt Technologies, Inc.
Reg #: 3016090213
·
FEI: 3016090213
·
Expires 2026
Products
11
Proprietary Names
14
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Blue Belt Technologies, Inc.
- Registration Number
- 3016090213
- FEI Number
- 3016090213
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252841
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-21 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2026-01-21 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2026-01-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-01-21 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2026-01-21 |
| Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | NJD | Class 2 | Orthopedic | No | 2024-03-28 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-03-15 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2017-05-05 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2017-05-05 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2017-05-05 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2025-07-11 |
Proprietary Names
REAL INTELLIGENCE CORI XT
Real Intelligence CORI
NAVIO
Real Intelligence Cori
Brainlab Knee
RI.HIP MODELER
STRIDE
CORIOGRAPH Pre-Op Planning and Modeling Services for Shoulder
REAL INTELLIGENCE CORI
REAL INTELLIGENCE CORI (CORI)
CORI
CORIOGRAPH Pre-Op Planning and Modeling Services
HIP7
RI.HIP NAVIGATION CORI
Establishment Types
Manufacture Medical Device