FDA.reportPublic FDA data

510(k) K211837

Device
Altus Spine Interbody Standalone Fusion System
Applicant
Altus Partners, LLC
510(k) number
K211837
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-19
Date received
2021-06-14
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark Melton
Address
1340 Enterprise Dr. West Chester PA US 19380 19380

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26