Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)— 510(k) K231326

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K231326 for Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching), Substantially Equivalent on 2023-05-31. Applicant: Osteonic Co., Ltd..

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2023-05-08
Decision date: 2023-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, 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.