MODIFICATION TO SYNTHES USS— 510(k) K000450

Substantially Equivalent

Synthes Spine

FDA 510(k) clearance K000450 for MODIFICATION TO SYNTHES USS, Substantially Equivalent on 2000-03-10. Applicant: Synthes Spine.

Clearance details

Applicant: Synthes Spine
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2000-02-11
Decision date: 2000-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Paoli, PA, 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.