Kinos Instrumentation

GUDID 00840097512044

Anatomic Flat-Cut Surface Trial, Right, Size 0

Restor3d, Inc.

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• Primary Device ID: 00840097512044
• NIH Device Record Key: 4e2c68d6-5270-4b11-b350-2e1933f580a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Instrumentation
• Version Model Number: 5801-2120
• 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	00840097512044 [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

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

[00840097512044]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [Kinos Instrumentation]

• 00840097512327: Kinos Tray - Bearing Caddy Lid
• 00840097512310: Kinos Tray - Bearing Caddy
• 00840097512303: Kinos Tray - Right Caddy Lid
• 00840097512297: Kinos Tray - Right Talar Caddy
• 00840097512280: Kinos Tray - Left Caddy Lid
• 00840097512273: Kinos Tray - Left Talar Caddy
• 00840097512266: Kinos Tray - Lid, Set 2
• 00840097512259: Kinos Tray - Top Level, Set 2
• 00840097512242: Kinos Tray - Base Level, Set 2
• 00840097512136: Bearing Thickness Trial, Size 4, 14mm
• 00840097512129: Bearing Thickness Trial, Size 3, 14mm
• 00840097512112: Bearing Thickness Trial, Size 2, 14mm
• 00840097512105: Bearing Thickness Trial, Size 1, 14mm
• 00840097512044: Anatomic Flat-Cut Surface Trial, Right, Size 0
• 00840097512037: Anatomic Flat-Cut Surface Trial, Left, Size 0
• 00840097512020: Anatomic Surface Chamfer Trial, Right, Size 0
• 00840097512006: Rail & Peg Guide, Size 0
• 00840097511993: Range Bearing Surface Trial, Size 4
• 00840097511986: Range Bearing Surface Trial, Size 3
• 00840097511979: Range Bearing Surface Trial, Size 2
• 00840097511962: Range Bearing Surface Trial, Size 0/1
• 00840097511955: Anatomic Bearing Surface Trial, Size 4
• 00840097511948: Anatomic Bearing Surface Trial, Size 3
• 00840097511931: Anatomic Bearing Surface Trial, Size 2
• 00840097511924: Anatomic Bearing Surface Trial, Size 1
• 00840097511917: Bearing Thickness Adapter, 16mm
• 00840097511900: Bearing Thickness Adapter, 15mm
• 00840097511894: Bearing Thickness Adapter, 14mm
• 00840097511887: Bearing Thickness Adapter, 13mm
• 00840097511870: Bearing Thickness Adapter, 12mm
• 00840097511863: Bearing Thickness Adapter, 11mm
• 00840097511856: Bearing Thickness Adapter, 10mm
• 00840097511849: Bearing Thickness Adapter, 9mm
• 00840097511832: Bearing Thickness Adapter, 8mm
• 00840097511825: Bearing Thickness Adapter, 7mm
• 00840097511818: Bearing Thickness Adapter, 6mm
• 00840097511801: Range Flat-Cut Surface Trial, Right, Size 4
• 00840097511795: Range Flat-Cut Surface Trial, Right, Size 3
• 00840097511788: Range Flat-Cut Surface Trial, Right, Size 2
• 00840097511771: Range Flat-Cut Surface Trial, Right, Size 1
• 00840097511764: Range Flat-Cut Surface Trial, Right, Size 0
• 00840097511757: Range Flat-Cut Surface Trial, Left, Size 4
• 00840097511740: Range Flat-Cut Surface Trial, Left, Size 3
• 00840097511733: Range Flat-Cut Surface Trial, Left, Size 2
• 00840097511726: Range Flat-Cut Surface Trial, Left, Size 1
• 00840097511719: Range Flat-Cut Surface Trial, Left, Size 0
• 00840097511702: Anatomic Flat-Cut Surface Trial, Right, Size 4
• 00840097511696: Anatomic Flat-Cut Surface Trial, Right, Size 3
• 00840097511689: Anatomic Flat-Cut Surface Trial, Right, Size 2
• 00840097511672: Anatomic Flat-Cut Surface Trial, Right, Size 1