Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)— 510(k) K243467

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K243467 for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching), Substantially Equivalent on 2024-12-03. Applicant: Osteonic Co., Ltd..

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2024-11-08
Decision date: 2024-12-03
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.