KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System— 510(k) K233947

Name: FDA 510(k) clearance K233947
Creator: U.S. Food and Drug Administration
Published: 2024-10-10

Substantially Equivalent

Ctl Medical Corporation

FDA 510(k) clearance K233947 for KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System, Substantially Equivalent on 2024-10-10. Applicant: Ctl Medical Corporation. Device class: 2.

Clearance details

Applicant: Ctl Medical Corporation
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-12-14
Decision date: 2024-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

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K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
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 Ctl Medical Corporation

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K231715 — MONDRIAN Anterior Lumbar Plate System2024-01-26
K231359 — RODIN Expandable Lumbar Cage System2023-06-09
K220513 — NITRO Interbody Fusion Cage System Family2023-04-25
K220334 — MONET Anterior Cervical Plate System2022-11-09
K211785 — CASSATT SIJ Fixation System2022-10-17

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.