FDA Registration
Active
🇺🇸 United States
Zimmer (LN) -POROUS TITANIUM ACETABULAR AUGMENTS
Reg #: 1450662
·
FEI: 1450662
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1450662
- FEI Number
- 1450662
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1880 Industrial Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052888
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, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2013-01-04 |
Proprietary Names
Zimmer (LN) -POROUS TITANIUM ACETABULAR AUGMENTS
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)