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

• 07630040737722 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 0S1
• 07630040737739 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 1S2
• 07630040737746 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 2SL1
• 07630040737753 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 2SL2
• 07630040737760 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 2SL3
• 07630040737777 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 3SL1
• 07630040737784 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 3SL2
• 07630040737791 - Surgical Manual Instrument: 2025-12-18 AMIS-K Broach Size 4SL1