STRYKER SPINE OASYS SYSTEM— 510(k) K032394

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K032394 for STRYKER SPINE OASYS SYSTEM, Substantially Equivalent on 2004-02-20. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2003-08-04
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.