Cleared Traditional

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants

K221894 · Globus Medical, Inc. · Orthopedic

Aug 2023

Decision

399d

Days

Class 2

Risk

About This 510(k) Submission

K221894 is an FDA 510(k) clearance for the Lumbar Expandable lnterbody Spacers -Additional Indications/Implants, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 3, 2023, 399 days after receiving the submission on June 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K221894 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2022
Decision Date	August 03, 2023
Days to Decision	399 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.