FDA Registration
Active
🇺🇸 United States
Global Unite (shoulder)
Reg #: 3027388160
·
FEI: 3027388160
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K101996
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, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2011-06-30 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2011-06-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2011-06-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2011-06-30 |
Proprietary Names
Global Unite (shoulder)
Establishment Types
Repack or Relabel Medical Device