FDA.reportPublic FDA data

510(k) K234087

Device
restor3d TIDAL Lumbar Interbody Fusion System
Applicant
Restor3D
510(k) number
K234087
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-22
Date received
2023-12-22
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anika Moorjani
Address
4001 E. Nc 54 Hwy., Suite 3160 Durham NC US 27709 27709

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
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K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
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K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24