The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Trabeculink Tibial Cones.
| Device ID | K200113 |
| 510k Number | K200113 |
| Device Name: | LINK TrabecuLink Tibial Cones |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Oststrabe 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Stefanie Fuchs Waldemar Link GmbH & Co. KG Oststrabe 4-10 Norderstedt, DE 22844 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575076536 | K200113 | 000 |
| 04026575192489 | K200113 | 000 |
| 04026575192472 | K200113 | 000 |
| 04026575192465 | K200113 | 000 |
| 04026575192458 | K200113 | 000 |
| 04026575192441 | K200113 | 000 |
| 04026575192434 | K200113 | 000 |
| 04026575192427 | K200113 | 000 |
| 04026575192410 | K200113 | 000 |
| 04026575192403 | K200113 | 000 |
| 04026575192526 | K200113 | 000 |
| 04026575192540 | K200113 | 000 |
| 04026575229024 | K200113 | 000 |
| 04026575212361 | K200113 | 000 |
| 04026575209712 | K200113 | 000 |
| 04026575209705 | K200113 | 000 |
| 04026575209699 | K200113 | 000 |
| 04026575209682 | K200113 | 000 |
| 04026575192588 | K200113 | 000 |
| 04026575192571 | K200113 | 000 |
| 04026575192557 | K200113 | 000 |
| 04026575187799 | K200113 | 000 |