Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)— 510(k) K202806

Name: FDA 510(k) clearance K202806
Creator: U.S. Food and Drug Administration
Published: 2021-06-17

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K202806 for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching), Substantially Equivalent on 2021-06-17. Applicant: Osteonic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-09-23
Decision date: 2021-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guro-Gu, KR

Download summary PDF View on FDA.gov ↗

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K251680 — Biosteon® Screw2026-02-17

More clearances from Osteonic Co., Ltd.

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K254182 — Aster2026-02-26
K243469 — SIGNEX2025-05-29
K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2024-12-03
K243470 — Fix2Lock (PEEK Self Punching)2024-12-03
K230546 — SIGNEX2024-06-11

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.