FDA.report

510(k) K243191

Device
Atlas Spine Lateral Expandable Interbody System
Applicant
Atlas Spine, Inc.
510(k) number
K243191
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-26
Date received
2024-09-30
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Thomas Smith
Address
1555 Jupiter Park Dr. Suite 1 Jupiter FL US 33458 33458

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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