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
Phone
973 6251333 ext. 119

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

Proprietary Names

MobileLink Acetabular Cup System - X-LINKed Inserts and TrabecuLink Augments

Establishment Types

Manufacture Medical Device