Catalyft PL Expandable Interbody System— 510(k) K253011

Name: FDA 510(k) clearance K253011
Creator: U.S. Food and Drug Administration
Published: 2026-07-17

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K253011 for Catalyft PL Expandable Interbody System, Substantially Equivalent on 2026-07-17. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-09-19
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K253420 — Admiral ACP System +18 more2026-07-01
K253151 — Fule Interbody Fusion Cage System2026-06-15

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K254165 — Infinity OCT System2026-01-21
K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)2026-01-07
K253129 — Infinity OCT System2025-10-24

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.