K800363 is an FDA 510(k) clearance for the PARKE-DAVIS TOTAL KNEE PROSTHESIS. This device is classified as a Caliper (Class I - General Controls, product code KTZ).
Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980, 19 days after receiving the submission on February 20, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4150.
| 510(k) Number | K800363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1980 |
| Decision Date | March 10, 1980 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KTZ — Caliper |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4150 |