MyKnee

GUDID 07630345784575

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

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630345784575
• NIH Device Record Key: d05f5766-962a-4540-8250-12226173943d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee
• Version Model Number: 6.1712SM
• 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	07630345784575 [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

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

[07630345784575]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-08
• Device Publish Date: 2023-11-30

On-Brand Devices [MyKnee]

• 07630030875267: MyKnee Crossover Tibia Cut Adapter MIS Left
• 07630030875243: MyKnee Crossover Tibia Cut Adapter MIS Right
• 07630030875229: MyKnee Crossover Tibia Cut Adapter STD
• 07630030875205: MyKnee Crossover Femur Adapter Even 4in1s
• 07630030875182: MyKnee Crossover Femur Adapter Odd 4in1s
• 07630030875168: MyKnee Crossover Femur Distal Adapter MIS
• 07630030875144: MyKnee Crossover Femur Distal Adapter STD
• 07630040733427: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#7
• 07630040733380: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#6
• 07630040733342: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#5
• 07630040733304: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#4
• 07630040733267: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#3
• 07630040733229: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#2
• 07630040733182: MyKnee Effic SLIM FemPinPosit-MRI-GMK-R-#1
• 07630040733168: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#7
• 07630040733120: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#6
• 07630040733083: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#5
• 07630040733045: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#4
• 07630040733007: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#3
• 07630040732963: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#2
• 07630040732925: MyKnee Effic SLIM FemPinPosit-MRI-GMK-L-#1
• 07630040715454: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#7
• 07630040715416: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#6
• 07630040715379: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#5
• 07630040715331: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#4
• 07630040715294: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#3
• 07630040715256: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#2
• 07630040715218: MyKnee Effic STD FemPinPosit-MRI-GMK-R-#1
• 07630040715195: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#7
• 07630040715157: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#6
• 07630040715119: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#5
• 07630040715072: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#4
• 07630040715034: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#3
• 07630040714990: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#2
• 07630040714952: MyKnee Effic STD FemPinPosit-MRI-GMK-L-#1
• 07630040714938: MyKnee STD TibPinPosit-MRI-GMK-RL-#6
• 07630040714914: MyKnee STD TibPinPosit-MRI-GMK-RL-#5
• 07630040714891: MyKnee STD TibPinPosit-MRI-GMK-RL-#4
• 07630040714877: MyKnee STD TibPinPosit-MRI-GMK-RL-#3
• 07630040714853: MyKnee STD TibPinPosit-MRI-GMK-RL-#2
• 07630040714839: MyKnee STD TibPinPosit-MRI-GMK-RL-#1
• 07630040714815: MyKnee STD TibPinPosit-MRI-GMK-LL-#6
• 07630040714792: MyKnee STD TibPinPosit-MRI-GMK-LL-#5
• 07630040714778: MyKnee STD TibPinPosit-MRI-GMK-LL-#4
• 07630040714754: MyKnee STD TibPinPosit-MRI-GMK-LL-#3
• 07630040714730: MyKnee STD TibPinPosit-MRI-GMK-LL-#2
• 07630040714716: MyKnee STD TibPinPosit-MRI-GMK-LL-#1
• 07630040714693: MyKnee STD TibPinPosit-MRI-GMK-RM-#6
• 07630040714679: MyKnee STD TibPinPosit-MRI-GMK-RM-#5
• 07630040714655: MyKnee STD TibPinPosit-MRI-GMK-RM-#4