Fix2Lock (PEEK Self Punching)— 510(k) K202763

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K202763 for Fix2Lock (PEEK Self Punching), Substantially Equivalent on 2021-06-04. Applicant: Osteonic Co., Ltd..

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2020-09-21
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guro-Gu, KR

Download summary PDF View on FDA.gov ↗

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.