Medical Device Manufacturer · US , Durham , NC

Restor3d

11 submissions · 11 cleared · Since 2020
11
Total
11
Cleared
0
Denied

Restor3d — FDA 510(k) Submissions

Restor3d has submitted 11 FDA 510(k) premarket notifications since 2020, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer, Intervertebral Fusion Device With Bone Graft, Lumbar, Screw, Fixation, Bone, Pin, Fixation, Smooth, Ankle Arthroplasty Implantation System . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Kinos Total Ankle System
K252454 · HSN Prosthesis, Ankle,... · Orthopedic
Sep 2025 30d
restor3d Reverse Total Shoulder Arthroplasty System
K243643 · PHX Shoulder Prosthesis,... · Orthopedic
May 2025 174d
Kinos Total Ankle System
K242868 · HSN Prosthesis, Ankle,... · Orthopedic
Oct 2024 28d
Kinos Total Ankle System
K241482 · HSN Prosthesis, Ankle,... · Orthopedic
Jul 2024 59d
restor3d TIDAL Lumbar Interbody Fusion System
K234087 · MAX Intervertebral Fusion... · Orthopedic
Jan 2024 31d
Kinos Axiom Total Ankle System
K232595 · HSN Prosthesis, Ankle,... · Orthopedic
Nov 2023 95d
Extremity Staple
K231458 · JDR Staple, Fixation, Bone · Orthopedic
Aug 2023 76d
Axiom PSR System
K223326 · OYK Ankle Arthroplasty... · Orthopedic
Mar 2023 150d
restor3d TiDAL Lumbar Interbody Fusion Device
K220523 · MAX Intervertebral Fusion... · Orthopedic
Jun 2022 114d
restor3d Pin Implants
K211789 · HTY Pin, Fixation, Smooth · Orthopedic
Jan 2022 208d
restor3d Metallic Interference Screw
K193491 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2020 93d
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