Cleared Traditional

Calibrate LTX Interbody System

K222455 · Alphatec Spine, Inc. · Orthopedic

Nov 2022

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K222455 is an FDA 510(k) clearance for the Calibrate 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 November 18, 2022, 95 days after receiving the submission on August 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222455 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2022
Decision Date	November 18, 2022
Days to Decision	95 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.