Cleared Traditional

IdentiTi? Porous Ti Interbody System, IdentiTi? NanoTec? Interbody System, Transcend? PEEK Interbody System, Transcend? NanoTec? Interbody System, IdentiTi? ALIF Standalone Interbody System, IdentiTi? NanoTec? ALIF Standalone Interbody System

K222028 · Alphatec Spine · Orthopedic

Oct 2022

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K222028 is an FDA 510(k) clearance for the IdentiTi? Porous Ti Interbody System, IdentiTi? NanoTec? Interbody System, Transcend? PEEK Interbody System, Transcend? NanoTec? Interbody System, IdentiTi? ALIF Standalone Interbody System, IdentiTi? NanoTec? ALIF Standalone Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Alphatec Spine (Carlsbad, US). The FDA issued a Cleared decision on October 7, 2022, 88 days after receiving the submission on July 11, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K222028 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2022
Decision Date	October 07, 2022
Days to Decision	88 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.