Kinos Axiom Instrumentation

GUDID 00840097505534

Trial Inserter

Restor3d

Joint prosthesis implantation kit, reusable
Primary Device ID00840097505534
NIH Device Record Key0e42edf9-f1a6-4624-b73c-68ae8fc043b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameKinos Axiom Instrumentation
Version Model Number5801-1039
Company DUNS080819836
Company NameRestor3d
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097505534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


[00840097505534]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-29
Device Publish Date2023-05-19

On-Brand Devices [Kinos Axiom Instrumentation]

00840097509426Bearing Removal Tool
00840097509419Tibial AP Sizer
00840097509167Lid
00840097508986Center Peg Drill
00840097508979Dual Talar Cut Guide
00840097508962Angel Wing
00840097508894Center Peg Drill, Non-Sterile
00840097508832Trial Caddie
00840097508825Accessory Caddie
00840097508818Tray Base
00840097508801Tray Level 2
00840097508795Tray Level 1
00840097508740Proximal Alignment Manifold
00840097508733Coupled Cut Guide
00840097508726Tibial recut guide
00840097507491Talar Rail Drill, Non-sterile
00840097506326Starter Broach
00840097506319Graphic Case 1
00840097506302Bearing Trial Size 4, Right, 12mm
00840097506296Bearing Trial Size 4, Right, 10mm
00840097506289Bearing Trial Size 4, Right, 8mm
00840097506272Bearing Trial Size 4, Right, 6mm
00840097506265Bearing Trial Size 3, Right, 12mm
00840097506258Bearing Trial Size 3, Right, 10mm
00840097506241Bearing Trial Size 3, Right, 8mm
00840097506234Bearing Trial Size 3, Right, 6mm
00840097506227Bearing Trial Size 2, Right, 12mm
00840097506210Bearing Trial Size 2, Right, 10mm
00840097506203Bearing Trial Size 2, Right, 8mm
00840097506197Bearing Trial Size 2, Right, 6mm
00840097506180Bearing Trial Size 1, Right, 12mm
00840097506173Bearing Trial Size 1, Right, 10mm
00840097506166Bearing Trial Size 1, Right, 8mm
00840097506159Bearing Trial Size 1, Right, 6mm
00840097506142Bearing Trial Size 4, Left, 12mm
00840097506135Bearing Trial Size 4, Left, 10mm
00840097506128Bearing Trial Size 4, Left, 8mm
00840097506111Bearing Trial Size 4, Left, 6mm
00840097506104Bearing Trial Size 3, Left, 12mm
00840097506098Bearing Trial Size 3, Left, 10mm
00840097506081Bearing Trial Size 3, Left, 8mm
00840097506074Bearing Trial Size 3, Left, 6mm
00840097506067Bearing Trial Size 2, Left, 12mm
00840097506050Bearing Trial Size 2, Left, 10mm
00840097506043Bearing Trial Size 2, Left, 8mm
00840097506036Bearing Trial Size 2, Left, 6mm
00840097506029Bearing Trial Size 1, Left, 12mm
00840097506012Bearing Trial Size 1, Left, 10mm
00840097506005Bearing Trial Size 1, Left, 8mm
00840097505992Bearing Trial Size 1, Left, 6mm

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