MODIFICATION TO: PSS SYSTEM— 510(k) K090033

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K090033 for MODIFICATION TO: PSS SYSTEM, Substantially Equivalent on 2009-05-06. Applicant: Spinal USA.

Clearance details

Applicant: Spinal USA
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2009-01-06
Decision date: 2009-05-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Pear, MS, 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.