MAXIMA ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K061002

Substantially Equivalent

U&I Corp.

FDA 510(k) clearance K061002 for MAXIMA ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2006-11-15. Applicant: U&I Corp..

Clearance details

Applicant: U&I Corp.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2006-04-11
Decision date: 2006-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijungbu, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.