FDA Registration
Active
🇺🇸 United States
Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
Reg #: 1424263
·
FEI: 3003015552
·
Expires 2025
Products
8
Proprietary Names
2
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1424263
- FEI Number
- 3003015552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2500 Commerce Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111663
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-09-08 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2021-09-08 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2021-09-08 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-09-08 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2021-09-08 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2021-09-08 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-09-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-09-08 |
Proprietary Names
Zimmer (LN,LS) - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
Zimmer (LN,LS) - TRAUMA INTERNAL FIXATION SYSTEMS
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)