The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Vario-cup System.
| Device ID | K221794 |
| 510k Number | K221794 |
| Device Name: | Vario-Cup System |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Pia Mueller |
| Correspondent | Mateusz Leszczak LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575395910 | K221794 | 000 |
| 04026575352791 | K221794 | 000 |
| 04026575352784 | K221794 | 000 |
| 04026575352777 | K221794 | 000 |
| 04026575352760 | K221794 | 000 |
| 04026575352753 | K221794 | 000 |