My Knee

GUDID 07630030865886

MyKnee FemDisCutBl-CT-GMK-LM-#4+ ST

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030865886
• NIH Device Record Key: a8ddadcc-a4fd-4503-96f0-6ca3d560567e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee
• Version Model Number: 4.1014SM
• 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	07630030865886 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [My Knee ]

• 07630030866043: MyKnee FemDisCutBl-CT-GMK-RM-#6+ ST
• 07630030866029: MyKnee FemDisCutBl-CT-GMK-RM-#5+ ST
• 07630030866005: MyKnee FemDisCutBl-CT-GMK-RM-#4+ ST
• 07630030865985: MyKnee FemDisCutBl-CT-GMK-RM-#3+ ST
• 07630030865961: MyKnee FemDisCutBl-CT-GMK-RM-#2+ ST
• 07630030865947: MyKnee FemDisCutBl-CT-GMK-RM-#1+ ST
• 07630030865923: MyKnee FemDisCutBl-CT-GMK-LM-#6+ ST
• 07630030865909: MyKnee FemDisCutBl-CT-GMK-LM-#5+ ST
• 07630030865886: MyKnee FemDisCutBl-CT-GMK-LM-#4+ ST
• 07630030865862: MyKnee FemDisCutBl-CT-GMK-LM-#3+ ST
• 07630030865848: MyKnee FemDisCutBl-CT-GMK-LM-#2+ ST
• 07630030865824: MyKnee FemDisCutBl-CT-GMK-LM-#1+ ST
• 07630030868047: MyKnee FemDisCutBl-MRI-GMK-RM-#4+ ST