Spinal Inner Fixation System— 510(k) K143013

Substantially Equivalent

Changzhou Dingjian Medical Appliance Co., Ltd.

FDA 510(k) clearance K143013 for Spinal Inner Fixation System, Substantially Equivalent on 2015-12-11. Applicant: Changzhou Dingjian Medical Appliance Co., Ltd..

Clearance details

Applicant: Changzhou Dingjian Medical Appliance Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2014-10-20
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, 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.