FDA Registration
Active
🇺🇸 United States
Hip Ball
Reg #: 3027388160
·
FEI: 3027388160
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Chicago Field Inventory Location (FIL)
- Registration Number
- 3027388160
- FEI Number
- 3027388160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 555 Busse Road
- City
- Elk Grove Village
- State
- IL
- ZIP
- 60007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K853655
Owner / Operator
- Firm Name
- DePuy Synthes, Inc.
- Operator Number
- 1818910
- Address
- 700 Orthopaedic Drive
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- 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 | 2015-06-16 |
Proprietary Names
Hip Ball
Establishment Types
Repack or Relabel Medical Device