K800800 is an FDA 510(k) clearance for the PATELLAR COMPONENT FOR LUBINUS PATELLAR. This device is classified as a Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented (Class II - Special Controls, product code HTG).
Submitted by Waldemar Link GmbH & Co. KG (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980, 11 days after receiving the submission on April 10, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3580.
| 510(k) Number | K800800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1980 |
| Decision Date | April 21, 1980 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTG — Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3580 |