Spinal fixation system— 510(k) K161151

Substantially Equivalent

Canwell Medical Co., Ltd.

FDA 510(k) clearance K161151 for Spinal fixation system, Substantially Equivalent on 2016-09-21. Applicant: Canwell Medical Co., Ltd..

Clearance details

Applicant: Canwell Medical Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2016-04-25
Decision date: 2016-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jinhua, CN

Download summary PDF View on FDA.gov ↗

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.