Skip to content

Catalyft LS Expandable Interbody System

by Medtronic Sofamor Danek USA, Inc.

510(k) K241992

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241992 Date28 Oct 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OVD
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Catalyft LS Expandable Interbody System is an Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), designed for spinal fusion procedures. It features expandable interbody cages that provide structural support and promote bone growth between adjacent vertebrae in the lumbar spine, facilitating spinal stabilization and fusion.

This system is supplied as a reusable surgical implant and is intended for use in controlled clinical settings, such as operating rooms. It is classified under FDA product code MAX and holds a Traditional 510(k) clearance (K241992) for substantial equivalence to prior-generation devices. Sterility and handling instructions are detailed in the manufacturer’s accompanying documentation, ensuring compliance with regulatory requirements for spinal implants.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →