FDA Registration
Active
🇩🇪 Germany
MobileLink Acetabular Cup System - X-LINKed Inserts and TrabecuLink Augments
Reg #: 3004371426
·
FEI: 3003386935
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Waldemar Link GmbH & Co. KG
- Registration Number
- 3004371426
- FEI Number
- 3003386935
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oststrasse 4-10
- City
- Norderstedt Schleswig-Holstein
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K241636
Owner / Operator
- Firm Name
- WALDEMAR LINK GMBH & CO. KG
- Operator Number
- 8010091
- Address
- BARKHAUSENWEG 10, --
- City
- HAMBURG
- State
- DE-NOTA
- Postal Code
- 22339
- Country
- DE
US Agent
- Business Name
- LinkBio Corp.
- Contact Name
- Jennifer Lubrecht
- Address
- 69 King Street
- City
- Dover
- State
- NJ
- ZIP
- 07801
- Country
- US
- [email protected]
- Phone
- 973 6251333 ext. 119
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-11-11 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-11-11 |
Proprietary Names
MobileLink Acetabular Cup System - X-LINKed Inserts and TrabecuLink Augments
Establishment Types
Manufacture Medical Device