Medical Device Manufacturer · US , Durham , NC

Restor3D, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2021

Recent clearances: Velora Acetabular System, iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System, TIDAL Fusion Cage System

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Restor3D, Inc. Orthopedic ✕

6 devices
1-6 of 6
Cleared Dec 05, 2025
Velora Acetabular System
K252067 · LPH
Orthopedic · 157d
Cleared Mar 27, 2025
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
K243768 · MBH
Orthopedic · 111d
Cleared Mar 24, 2025
TIDAL Fusion Cage System
K242356 · SAI
Orthopedic · 228d
Cleared Apr 29, 2024
restor3d Kinos Axiom Total Ankle System
K240591 · HSN
Orthopedic · 59d
Cleared May 25, 2022
restor3d MTP Implant
K201393 · KWD
Orthopedic · 728d
Cleared Jun 17, 2021
Restor3d Utility Wedge
K201314 · PLF
Orthopedic · 395d
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