510(k) K111995— XINGTM SPINE SYSTEM

Substantially Equivalent

Implanova Co., Ltd.

Clearance details

Applicant: Implanova Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2011-07-13
Decision date: 2011-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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.