K820002 is an FDA 510(k) clearance for the BARD CONTOUR LINK S.K.I. KNEE SYS. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982, 143 days after receiving the submission on January 4, 1982.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K820002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 1982 |
| Decision Date | May 27, 1982 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |