FDA Registration
Active
🇺🇸 United States
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
Reg #: 3008812560
·
FEI: 3008812560
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
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
- K211051
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-06-16 |
Proprietary Names
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198