Cleared Traditional

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System

K231438 · Alphatec Spine, Inc. · Orthopedic

Jul 2023

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K231438 is an FDA 510(k) clearance for the Calibrate PSX Interbody System, Calibrate NanoTec PSX 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 July 13, 2023, 57 days after receiving the submission on May 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K231438 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 2023
Decision Date	July 13, 2023
Days to Decision	57 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.