My Knee Bone Models

GUDID 07630030855153

MyKnee MIS Femur Bone Model Left Lateral

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030855153
• NIH Device Record Key: eb0293f5-b65f-45b6-bfd4-cd29d59d7ae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee Bone Models
• Version Model Number: 4.9211
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: 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	07630030855153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093806

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

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

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

[07630030855153]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-11-18

On-Brand Devices [My Knee Bone Models]

• 07630030855276: MyKnee MIS Tibial Bone Model Right Lateral
• 07630030855252: MyKnee MIS Tibial Bone Model Right Medial
• 07630030855238: MyKnee MIS Tibial Bone Model Left Lateral
• 07630030855214: MyKnee MIS Tibial Bone Model Left Medial
• 07630030855191: MyKnee MIS Femur Bone Model Right Lateral
• 07630030855177: MyKnee MIS Femur Bone Model Right Medial
• 07630030855153: MyKnee MIS Femur Bone Model Left Lateral
• 07630030855139: MyKnee MIS Femur Bone Model Left Medial
• 07630030855115: MyKnee Tibial Bone Model Right
• 07630030855092: MyKnee Tibial Bone Model Left
• 07630030855078: MyKnee Femur Bone Model Right
• 07630030855054: MyKnee Femur Bone Model Left