Kinos Axiom Instrumentation

GUDID 00840097509051

X-Stem Tibial Trial, Size 3

Restor3d, Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00840097509051
• NIH Device Record Key: 517bacf6-2780-4ccc-92fa-62840e793e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Axiom Instrumentation
• Version Model Number: 5801-4033
• Company DUNS: 080819836
• Company Name: Restor3d, Inc.
• 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	00840097509051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232595

FDA Product Code

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

Sterilization

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

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

[00840097509051]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [Kinos Axiom Instrumentation]

• 00840097510323: Bone Removal Screw, Sterile
• 00840097510125: X-Stem Finish Broach S45, Tall
• 00840097510118: X-Stem Finish Broach S45, Short
• 00840097510101: X-Stem Finish Broach S123, Tall
• 00840097510095: X-Stem Finish Broach S123, Short
• 00840097509150: X-Stem Broach S45, Tall
• 00840097509143: X-Stem Broach S45, Short
• 00840097509136: X-Stem Broach S123, Tall
• 00840097509129: X-Stem Broach S123, Short
• 00840097509112: Spike Broach
• 00840097509105: Spike Broach, Short
• 00840097509099: Drill Plate, Size 45
• 00840097509082: Drill Plate, Size 123
• 00840097509075: X-Stem Tibial Trial, Size 5
• 00840097509068: X-Stem Tibial Trial, Size 4
• 00840097509051: X-Stem Tibial Trial, Size 3
• 00840097509044: X-Stem Tibial Trial, Size 2
• 00840097509037: X-Stem Tibial Trial, Size 1
• 00840097509464: 16mm RAD Drill Tip, Sterile
• 00840097509457: 13mm RAD Drill Tip, Sterile
• 00840097509440: 9mm RAD Drill Tip, Sterile
• 00840097509433: Right Angle Drill Driving Shaft, Sterile
• 00840097509402: Right Angle Drill Driving Shaft, Non-Sterile
• 00840097509020: Right Angle Drill Tip 16mm, Non-Sterile
• 00840097509013: Right Angle Drill Tip 13mm, Non-Sterile
• 00840097509006: Right Angle Drill Tip 9mm, Non-Sterile
• 00840097508993: Right Angle Drill
• 00840097512365: Kinos Tray - Accessory Caddy Lid
• 00840097512358: Straight Chisel
• 00840097512341: Slotted Mallet
• 00840097512334: Pin Puller
• 00840097512051: Parallel Distractor Sleeve
• 00840097511412: Talar Recut Guide
• 00840097512440: 50.8mm x 1.21mm Reciprocating Saw Blade, Conmed
• 00840097512433: 50.8mm x 1.21mm Reciprocating Saw Blade, Synthes