HC Spinal System— 510(k) K151362

Substantially Equivalent

Hung Chun Bio-S Co., Ltd.

FDA 510(k) clearance K151362 for HC Spinal System, Substantially Equivalent on 2016-05-05. Applicant: Hung Chun Bio-S Co., Ltd..

Clearance details

Applicant: Hung Chun Bio-S Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2015-05-21
Decision date: 2016-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung, TW

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.