restor3d Kinos Axiom Total Ankle System

GUDID 00840097505091

Tibial Implant, Size 4, Left, with Tidal Technology

Restor3d, Inc.

Fixed-bearing total ankle prosthesis
Primary Device ID00840097505091
NIH Device Record Key9235c785-5f95-4fbb-ac82-b83d4c650db4
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Kinos Axiom Total Ankle System
Version Model Number1831.1140
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097505091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-11-02
Device Publish Date2022-12-29

On-Brand Devices [restor3d Kinos Axiom Total Ankle System]

00840097505206Tibial Implant, Size 5, Long Right, with Tidal Technology
00840097505190Tibial Implant, Size 5, Right, with Tidal Technology
00840097505183Tibial Implant, Size 4, Long Right, with Tidal Technology
00840097505176Tibial Implant, Size 4, Right, with Tidal Technology
00840097505169Tibial Implant, Size 3, Long Right, with Tidal Technology
00840097505152Tibial Implant, Size 3, Right, with Tidal Technology
00840097505145Tibial Implant, Size 2, Right, with Tidal Technology
00840097505138Tibial Implant, Size 1, Right, with Tidal Technology
00840097505121Tibial Implant, Size 5, Long Left, with Tidal Technology
00840097505114Tibial Implant, Size 5, Left, with Tidal Technology
00840097505107Tibial Implant, Size 4, Long Left, with Tidal Technology
00840097505091Tibial Implant, Size 4, Left, with Tidal Technology
00840097505084Tibial Implant, Size 3, Long Left, with Tidal Technology
00840097505077Tibial Implant, Size 3, Left, with Tidal Technology
00840097505060Tibial Implant, Size 2, Left, with Tidal Technology
00840097505053Tibial Implant, Size 1, Left, with Tidal Technology

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