The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Trabeculink Femoral Cones.
| Device ID | K201364 |
| 510k Number | K201364 |
| Device Name: | LINK TrabecuLink Femoral Cones |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Terry Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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