Kinos Axiom Instrumentation 5801.0050

GUDID 00840097507507

Talar Bone Mill, Size 1

Restor3d

Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use Joint prosthesis implantation kit, single-use

• Primary Device ID: 00840097507507
• NIH Device Record Key: a7dd9d01-42c0-44fa-a2d1-717f383340c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Axiom Instrumentation
• Version Model Number: 5801-0050
• Catalog Number: 5801.0050
• Company DUNS: 080819836
• Company Name: Restor3d
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097507507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192778

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

[00840097507507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

On-Brand Devices [Kinos Axiom Instrumentation]

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