K843219 is an FDA 510(k) clearance for the ZIMMER BONE CEMENT CENTRIFUGATION SYS. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 29, 1984, 106 days after receiving the submission on August 15, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4210.
| 510(k) Number | K843219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1984 |
| Decision Date | November 29, 1984 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDZ — Mixer, Cement, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4210 |