Fixone Biocomposite Anchor— 510(k) K171299

Substantially Equivalent

Aju Pharm Co., Ltd.

FDA 510(k) clearance K171299 for Fixone Biocomposite Anchor, Substantially Equivalent on 2017-08-24. Applicant: Aju Pharm Co., Ltd..

Clearance details

Applicant: Aju Pharm Co., Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2017-05-03
Decision date: 2017-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.