FDA Registration
Active
🇮🇪 Ireland
Aequalis Reversed Fracture Shoulder Prosthesis
Reg #: 3008337808
·
FEI: 3008337808
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Stryker Macroom
- Registration Number
- 3008337808
- FEI Number
- 3008337808
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hartnetts Cross, Macroom
- City
- Co Cork Munster
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K131231
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-04-23 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2021-04-23 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2021-04-23 |
Proprietary Names
Aequalis Reversed Fracture Shoulder Prosthesis
Aequalis Shoulder Fracture System
Aequalis Reversed Shoulder Prosthesis
Establishment Types
Manufacture Medical Device