FDA.reportPublic FDA data

510(k) K242356

Device
TIDAL Fusion Cage System
Applicant
Restor3D, Inc.
510(k) number
K242356
Product code
SAI
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-24
Date received
2024-08-08
Regulation
888.3020
Classification name
Ankle Fusion Cage
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brianna Prindle
Address
4001 Nc-54 Hwy. Suite 3160 Durham NC US 27709 27709

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230088Ankle Truss System (ATS)4Web Medical, Inc.2024-03-21