Fix2Lock (PEEK Self Punching)— 510(k) K243470

Name: FDA 510(k) clearance K243470
Creator: U.S. Food and Drug Administration
Published: 2024-12-03

Substantially Equivalent

Osteonic Co., Ltd.

FDA 510(k) clearance K243470 for Fix2Lock (PEEK Self Punching), Substantially Equivalent on 2024-12-03. Applicant: Osteonic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osteonic Co., Ltd.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
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 ↗

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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
K230546 — SIGNEX2024-06-11
K233659 — Suture Wing2023-12-26

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.