Kinos Total Ankle Replacement

GUDID 00840097510347

Range Flat-Cut Talar Implant, Size 1, Left, with Tidal Technology

Restor3d, Inc.

Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis Coated ankle talus prosthesis

• Primary Device ID: 00840097510347
• NIH Device Record Key: e3722c43-a3a9-4bcd-a751-8e11a7809807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Total Ankle Replacement
• Version Model Number: 2833-1001
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00840097510347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240591

FDA Product Code

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

Sterilization

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

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 Total Ankle Replacement]

• 00840097511405: Range Bearing Implant, Size 4, Right, 16mm
• 00840097511399: Range Bearing Implant, Size 4, Right, 15mm
• 00840097511382: Range Bearing Implant, Size 4, Right, 14mm
• 00840097511375: Range Bearing Implant, Size 4, Right, 13mm
• 00840097511368: Range Bearing Implant, Size 4, Right, 12mm
• 00840097511351: Range Bearing Implant, Size 4, Right, 11mm
• 00840097511344: Range Bearing Implant, Size 4, Right, 10mm
• 00840097511337: Range Bearing Implant, Size 4, Right, 9mm
• 00840097511320: Range Bearing Implant, Size 4, Right, 8mm
• 00840097511313: Range Bearing Implant, Size 4, Right, 7mm
• 00840097511306: Range Bearing Implant, Size 4, Right, 6mm
• 00840097511290: Range Bearing Implant, Size 3, Right, 16mm
• 00840097511283: Range Bearing Implant, Size 3, Right, 15mm
• 00840097511276: Range Bearing Implant, Size 3, Right, 14mm
• 00840097511269: Range Bearing Implant, Size 3, Right, 13mm
• 00840097511252: Range Bearing Implant, Size 3, Right, 12mm
• 00840097511245: Range Bearing Implant, Size 3, Right, 11mm
• 00840097511238: Range Bearing Implant, Size 3, Right, 10mm
• 00840097511221: Range Bearing Implant, Size 3, Right, 9mm
• 00840097511214: Range Bearing Implant, Size 3, Right, 8mm
• 00840097511207: Range Bearing Implant, Size 3, Right, 7mm
• 00840097511191: Range Bearing Implant, Size 3, Right, 6mm
• 00840097511184: Range Bearing Implant, Size 2, Right, 16mm
• 00840097511177: Range Bearing Implant, Size 2, Right, 15mm
• 00840097511160: Range Bearing Implant, Size 2, Right, 14mm
• 00840097511153: Range Bearing Implant, Size 2, Right, 13mm
• 00840097511146: Range Bearing Implant, Size 2, Right, 12mm
• 00840097511139: Range Bearing Implant, Size 2, Right, 11mm
• 00840097511122: Range Bearing Implant, Size 2, Right, 10mm
• 00840097511115: Range Bearing Implant, Size 2, Right, 9mm
• 00840097511108: Range Bearing Implant, Size 2, Right, 8mm
• 00840097511092: Range Bearing Implant, Size 2, Right, 7mm
• 00840097511085: Range Bearing Implant, Size 2, Right, 6mm
• 00840097511078: Range Bearing Implant, Size 0/1, Right, 16mm
• 00840097511061: Range Bearing Implant, Size 0/1, Right, 15mm
• 00840097511054: Range Bearing Implant, Size 0/1, Right, 14mm
• 00840097511047: Range Bearing Implant, Size 0/1, Right, 13mm
• 00840097511030: Range Bearing Implant, Size 0/1, Right, 12mm
• 00840097511023: Range Bearing Implant, Size 0/1, Right, 11mm
• 00840097511016: Range Bearing Implant, Size 0/1, Right, 10mm
• 00840097511009: Range Bearing Implant, Size 0/1, Right, 9mm
• 00840097510996: Range Bearing Implant, Size 0/1, Right, 8mm
• 00840097510989: Range Bearing Implant, Size 0/1, Right, 7mm
• 00840097510972: Range Bearing Implant, Size 0/1, Right, 6mm
• 00840097510965: Range Bearing Implant, Size 4, Left, 16mm
• 00840097510958: Range Bearing Implant, Size 4, Left, 15mm
• 00840097510941: Range Bearing Implant, Size 4, Left, 14mm
• 00840097510934: Range Bearing Implant, Size 4, Left, 13mm
• 00840097510927: Range Bearing Implant, Size 4, Left, 12mm
• 00840097510910: Range Bearing Implant, Size 4, Left, 11mm