K111690

Substantially Equivalent

DEVINE SPINAL SYSTEM

Applicant: Changzhou Orthmed Medical Instrument Co., Ltd.
Product code: MNH
Advisory panel: Orthopedic
Date received: 2011-06-16
Decision date: 2011-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.