FDA Registration
Active
🇺🇸 United States
Depuy (NR,CH1) - SIGMA® High Performance Partial Knee System
Reg #: 1319660
·
FEI: 1000136478
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1319660
- FEI Number
- 1000136478
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23 ELIZABETH DR.
- City
- CHESTER
- State
- NY
- ZIP
- 10918
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193549
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2022-07-08 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2022-07-08 |
Proprietary Names
Depuy (NR,CH1) - SIGMA® High Performance Partial Knee System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)