K222423

Substantially Equivalent

Fixone All Suture Anchor

Applicant: Aju Pharm Co., Ltd.
Product code: MBI
Advisory panel: Orthopedic
Date received: 2022-08-11
Decision date: 2023-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.