FDA Registration
Active
🇺🇸 United States
Globus4330 (PL) - BIOLOX DELTA
Reg #: 2246552
·
FEI: 2246552
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Isomedix Operations Inc.
- Registration Number
- 2246552
- FEI Number
- 2246552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3459 SOUTH CLINTON AVE.
- City
- S Plainfield
- State
- NJ
- ZIP
- 07080
- Country
- US
Regulatory Submissions
- 510(k) Number
- K094035
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 9072619
- Address
- 5960 Heisley Road, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2023-08-23 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2023-08-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-08-23 |
Proprietary Names
Globus4330 (PL) - BIOLOX DELTA
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)