PSS SYSTEM— 510(k) K071438

Substantially Equivalent

Spinal USA

FDA 510(k) clearance K071438 for PSS SYSTEM, Substantially Equivalent on 2007-08-21. Applicant: Spinal USA.

Clearance details

Applicant: Spinal USA
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2007-05-23
Decision date: 2007-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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.