U & I AMERICA SPINAL HOOK SYSTEM— 510(k) K031595

Substantially Equivalent

U&I Corp., America

FDA 510(k) clearance K031595 for U & I AMERICA SPINAL HOOK SYSTEM, Substantially Equivalent on 2003-06-24. Applicant: U&I Corp., America.

Clearance details

Applicant: U&I Corp., America
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2003-05-21
Decision date: 2003-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.