K801574 is an FDA 510(k) clearance for the DEPALMA ELBOW. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II - Special Controls, product code JDB).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 114 days after receiving the submission on July 9, 1980.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K801574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDB — Prosthesis, Elbow, Semi-constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3160 |