MIX EVAC II— 510(k) K854077

Substantially Equivalent for Some Indications

Stryker Corp.

FDA 510(k) clearance K854077 for MIX EVAC II, Substantially Equivalent for Some Indications on 1986-01-31. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code JDZ
Advisory panel: Orthopedic
Date received: 1985-10-07
Decision date: 1986-01-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDZ

product code JDZ

Malfunction: 461
Total: 461

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.