Cleared Traditional

Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

K223153 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Dec 2022

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K223153 is an FDA 510(k) clearance for the Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 16, 2022, 71 days after receiving the submission on October 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223153 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 06, 2022
Decision Date	December 16, 2022
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.