K821476 is an FDA 510(k) clearance for the BARD ENDO LINK INTRACONDYLAR ROTATING. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1982, 36 days after receiving the submission on May 18, 1982.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K821476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1982 |
| Decision Date | June 23, 1982 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |