Medical Device Manufacturer · US , Durham , NC

Restor3d - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2020

Recent clearances: Veritas Reverse Total Shoulder System, Kinos Total Ankle System, restor3d Reverse Total Shoulder Arthroplasty System

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Restor3d Orthopedic ✕

13 devices
1-13 of 13
Cleared Jul 01, 2026
Veritas Shoulder System
K260556 · PHX
Orthopedic · 132d
Cleared May 07, 2026
Veritas Reverse Total Shoulder System
K253992 · PHX
Orthopedic · 146d
Cleared Sep 03, 2025
Kinos Total Ankle System
K252454 · HSN
Orthopedic · 30d
Cleared May 19, 2025
restor3d Reverse Total Shoulder Arthroplasty System
K243643 · PHX
Orthopedic · 174d
Cleared Oct 18, 2024
Kinos Total Ankle System
K242868 · HSN
Orthopedic · 28d
Cleared Jul 22, 2024
Kinos Total Ankle System
K241482 · HSN
Orthopedic · 59d
Cleared Jan 22, 2024
restor3d TIDAL Lumbar Interbody Fusion System
K234087 · MAX
Orthopedic · 31d
Cleared Nov 28, 2023
Kinos Axiom Total Ankle System
K232595 · HSN
Orthopedic · 95d
Cleared Aug 03, 2023
Extremity Staple
K231458 · JDR
Orthopedic · 76d
Cleared Mar 30, 2023
Axiom PSR System
K223326 · OYK
Orthopedic · 150d
Cleared Jun 17, 2022
restor3d TiDAL Lumbar Interbody Fusion Device
K220523 · MAX
Orthopedic · 114d
Cleared Jan 04, 2022
restor3d Pin Implants
K211789 · HTY
Orthopedic · 208d
Cleared Mar 19, 2020
restor3d Metallic Interference Screw
K193491 · HWC
Orthopedic · 93d
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