MyKnee STD

GUDID 07630030889325

MyKnee STD FemDisCutBl-CT-GMK-RM-#2

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030889325
• NIH Device Record Key: c3600b5f-3141-429d-8fec-30e9331a83e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee STD
• Version Model Number: 6.1022
• 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	07630030889325 [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

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

[07630030889325]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-21
• Device Publish Date: 2021-01-13

On-Brand Devices [MyKnee STD]

• 07630030891090: MyKnee STD FemDisCutBl-MRI-GMK-RM-#7
• 07630030891076: MyKnee STD FemDisCutBl-MRI-GMK-RM-#6
• 07630030891052: MyKnee STD FemDisCutBl-MRI-GMK-RM-#5
• 07630030891038: MyKnee STD FemDisCutBl-MRI-GMK-RM-#4
• 07630030891014: MyKnee STD FemDisCutBl-MRI-GMK-RM-#3
• 07630030890994: MyKnee STD FemDisCutBl-MRI-GMK-RM-#2
• 07630030890970: MyKnee STD FemDisCutBl-MRI-GMK-RM-#1
• 07630030890963: MyKnee STD FemDisCutBl-MRI-GMK-LM-#7
• 07630030890949: MyKnee STD FemDisCutBl-MRI-GMK-LM-#6
• 07630030890925: MyKnee STD FemDisCutBl-MRI-GMK-LM-#5
• 07630030890901: MyKnee STD FemDisCutBl-MRI-GMK-LM-#4
• 07630030890888: MyKnee STD FemDisCutBl-MRI-GMK-LM-#3
• 07630030889424: MyKnee STD FemDisCutBl-CT-GMK-RM-#7
• 07630030889400: MyKnee STD FemDisCutBl-CT-GMK-RM-#6
• 07630030889387: MyKnee STD FemDisCutBl-CT-GMK-RM-#5
• 07630030889363: MyKnee STD FemDisCutBl-CT-GMK-RM-#4
• 07630030889349: MyKnee STD FemDisCutBl-CT-GMK-RM-#3
• 07630030889325: MyKnee STD FemDisCutBl-CT-GMK-RM-#2
• 07630030889295: MyKnee STD FemDisCutBl-CT-GMK-LM-#7
• 07630030889271: MyKnee STD FemDisCutBl-CT-GMK-LM-#6
• 07630030889257: MyKnee STD FemDisCutBl-CT-GMK-LM-#5
• 07630030889233: MyKnee STD FemDisCutBl-CT-GMK-LM-#4
• 07630030889219: MyKnee STD FemDisCutBl-CT-GMK-LM-#3
• 07630030889196: MyKnee STD FemDisCutBl-CT-GMK-LM-#2
• 07630030889172: MyKnee STD FemDisCutBl-CT-GMK-LM-#1