Cleared Traditional

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

K242147 · Alphatec Spine, Inc. · Orthopedic

Sep 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K242147 is an FDA 510(k) clearance for the Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 20, 2024, 59 days after receiving the submission on July 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242147 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2024
Decision Date	September 20, 2024
Days to Decision	59 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.