UCR SPINAL SYSTEM— 510(k) K032739

Substantially Equivalent

Seaspine

FDA 510(k) clearance K032739 for UCR SPINAL SYSTEM, Substantially Equivalent on 2003-11-20. Applicant: Seaspine.

Clearance details

Applicant: Seaspine
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2003-09-04
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.