FDA Registration
Active
🇺🇸 United States
MR Conditional
Reg #: 3008812560
·
FEI: 3008812560
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Synthes (USA) Products LLC
- Registration Number
- 3008812560
- FEI Number
- 3008812560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1301 Goshen Pkwy
- City
- West Chester
- State
- PA
- ZIP
- 19380
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160553
Owner / Operator
- Firm Name
- SYNTHES (USA) Products LLC / Medical Device Business Service
- Operator Number
- 2520274
- Address
- 1301 Goshen Parkway, --
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2017-07-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-07-11 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2017-07-11 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-07-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-07-11 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2017-07-11 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-07-11 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2017-07-11 |
Proprietary Names
MR Conditional
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility