Cleared Traditional

Adaptix Interbody System with Titan nanoLOCK Surface Technology

K201267 · Medtronic Sofamor Danek · Orthopedic

Aug 2020

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K201267 is an FDA 510(k) clearance for the Adaptix Interbody System with Titan nanoLOCK Surface Technology, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 26, 2020, 106 days after receiving the submission on May 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K201267 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2020
Decision Date	August 26, 2020
Days to Decision	106 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.