U&I, OPTIMA, SPINAL SYSTEM— 510(k) K031585

Substantially Equivalent

U&I Corp., America

FDA 510(k) clearance K031585 for U&I, OPTIMA, SPINAL SYSTEM, Substantially Equivalent on 2003-06-27. Applicant: U&I Corp., America.

Clearance details

Applicant: U&I Corp., America
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2003-05-21
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Murray, UT, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.