MyKnee guides

GUDID 07630345784544

MyKnee Eff STYLUS FemDisCutBl-CT-GMK-LM-#2

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630345784544
• NIH Device Record Key: b58bd83c-491e-4133-851e-955b53548b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee guides
• Version Model Number: 6.1712
• 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	07630345784544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093806

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

[07630345784544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

Devices Manufactured by Medacta International SA

• 07630542774034 - Surgical Manual Instrument: 2026-02-04 AMIS Instruments tray–single level–S1000
• 07630345728975 - Navigation System for Knee surgery: 2026-02-03 iMNS Navigator
• 07630699701792 - Navigation System for Knee surgery: 2026-02-03 iMNS Navigator x US
• 07630040716574 - My Spine guides: 2026-01-30 MySpine LP drill pilot guide T01 STERILE
• 07630040716598 - My Spine guides: 2026-01-30 MySpine LP drill pilot guide T02 STERILE
• 07630040716611 - My Spine guides: 2026-01-30 MySpine LP drill pilot guide T03 STERILE
• 07630040716635 - My Spine guides: 2026-01-30 MySpine LP drill pilot guide T04 STERILE
• 07630040716659 - My Spine guides: 2026-01-30 MySpine LP drill pilot guide T05 STERILE