FIX-L PEEK PLIF and T-PLIF System— 510(k) K243973

Name: FDA 510(k) clearance K243973
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K243973 for FIX-L PEEK PLIF and T-PLIF System, Substantially Equivalent on 2025-06-12. Applicant: Jeil Medical Corporation. Device class: 2.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-12-23
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Jeil Medical Corporation

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K252246 — Leforte MMF System2026-04-02
K252826 — ARIX Femur Nail System2025-12-10
K251431 — FIX-C PEEK ACIF SA System2025-06-27
K242751 — ARIX Pectus Bar System2025-05-30
K242247 — ARIX Femur Nail System2025-04-22

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.