K162189

Substantially Equivalent

ANAX 5.5 Spinal System

Applicant: U&I Corporation
Product code: MNH
Advisory panel: Orthopedic
Date received: 2016-08-04
Decision date: 2016-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijeongbu-Si, KR

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.