The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Mobilelink® Acetabular Cup System - Dual Mobility Liners, And Shell/insert Adapters.
| Device ID | K200607 |
| 510k Number | K200607 |
| Device Name: | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, And Shell/Insert Adapters |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt, DE 22844 |
| Contact | Stafanie Fuchs |
| Correspondent | Stefanie Fuchs Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt, DE 22844 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2021-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575274222 | K200607 | 000 |
| 04026575208401 | K200607 | 000 |
| 04026575192373 | K200607 | 000 |