The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Endo-model Evo Knee System.
| Device ID | K220628 |
| 510k Number | K220628 |
| Device Name: | LINK Endo-Model EVO Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Terry Powell LinkBio Corp 69 King Street Dover, NJ 07801 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575291427 | K220628 | 000 |
| 04026575289547 | K220628 | 000 |
| 04026575289509 | K220628 | 000 |
| 04026575289455 | K220628 | 000 |
| 04026575289448 | K220628 | 000 |
| 04026575289431 | K220628 | 000 |
| 04026575289226 | K220628 | 000 |
| 04026575289202 | K220628 | 000 |
| 04026575289189 | K220628 | 000 |
| 04026575289165 | K220628 | 000 |
| 04026575288878 | K220628 | 000 |
| 04026575288854 | K220628 | 000 |
| 04026575288830 | K220628 | 000 |
| 04026575288816 | K220628 | 000 |
| 04026575288663 | K220628 | 000 |
| 04026575288656 | K220628 | 000 |
| 04026575289561 | K220628 | 000 |
| 04026575289578 | K220628 | 000 |
| 04026575289592 | K220628 | 000 |
| 04026575291403 | K220628 | 000 |
| 04026575291380 | K220628 | 000 |
| 04026575291366 | K220628 | 000 |
| 04026575291342 | K220628 | 000 |
| 04026575291328 | K220628 | 000 |
| 04026575291304 | K220628 | 000 |
| 04026575291281 | K220628 | 000 |
| 04026575290437 | K220628 | 000 |
| 04026575290369 | K220628 | 000 |
| 04026575290314 | K220628 | 000 |
| 04026575290284 | K220628 | 000 |
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| 04026575290246 | K220628 | 000 |
| 04026575290222 | K220628 | 000 |
| 04026575290178 | K220628 | 000 |
| 04026575288595 | K220628 | 000 |