Cleared Traditional

Calibrate CCX Interbody System

K232504 · Alphatec Spine, Inc. · Orthopedic

Oct 2023

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K232504 is an FDA 510(k) clearance for the Calibrate CCX 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 October 13, 2023, 56 days after receiving the submission on August 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K232504 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2023
Decision Date	October 13, 2023
Days to Decision	56 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.