The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Patellar Component For Lubinus Patellar.
| Device ID | K800800 |
| 510k Number | K800800 |
| Device Name: | PATELLAR COMPONENT FOR LUBINUS PATELLAR |
| Classification | Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTG |
| CFR Regulation Number | 888.3580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-10 |
| Decision Date | 1980-04-21 |