MODIFICATION TO: OASYS SYSTEM— 510(k) K093670

Substantially Equivalent

Stryker Spine

FDA 510(k) clearance K093670 for MODIFICATION TO: OASYS SYSTEM, Substantially Equivalent on 2010-03-18. Applicant: Stryker Spine.

Clearance details

Applicant: Stryker Spine
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2009-11-27
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.