Kinos Total Ankle Replacement

GUDID 00840097511344

Range Bearing Implant, Size 4, Right, 10mm

Restor3d, Inc.

Ankle prosthesis bearing

• Primary Device ID: 00840097511344
• NIH Device Record Key: 78113021-eb9a-48e4-8b1d-0675ba029503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinos Total Ankle Replacement
• Version Model Number: 3832-2410
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00840097511344 [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