K854077 is an FDA 510(k) clearance for the MIX EVAC II. This device is classified as a Mixer, Cement, For Clinical Use (Class I - General Controls, product code JDZ).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 31, 1986, 116 days after receiving the submission on October 7, 1985.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4210.
| 510(k) Number | K854077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 07, 1985 |
| Decision Date | January 31, 1986 |
| Days to Decision | 116 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 |