JOINIX CANNULAR SYSTEM— 510(k) K162070

Substantially Equivalent

Aju Pharm Co., Ltd.

FDA 510(k) clearance K162070 for JOINIX CANNULAR SYSTEM, Substantially Equivalent on 2017-03-16. Applicant: Aju Pharm Co., Ltd..

Clearance details

Applicant: Aju Pharm Co., Ltd.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2016-07-27
Decision date: 2017-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.