MyKnee MIS

GUDID 07630030849701

MyKnee MIS TibCutBl -CT- GMK -LL- #1 -STERILE

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030849701
• NIH Device Record Key: fd5b9234-20eb-4a82-9bea-25b200d16129
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee MIS
• Version Model Number: 4.1281S
• 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	07630030849701 [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 [MyKnee MIS]

• 07630030889943: MyKnee MIS FemDisCutBl-CT-GMK-RM-#7
• 07630030889929: MyKnee MIS FemDisCutBl-CT-GMK-RM-#6
• 07630030889905: MyKnee MIS FemDisCutBl-CT-GMK-RM-#5
• 07630030889882: MyKnee MIS FemDisCutBl-CT-GMK-RM-#4
• 07630030889868: MyKnee MIS FemDisCutBl-CT-GMK-RM-#3
• 07630030889844: MyKnee MIS FemDisCutBl-CT-GMK-RM-#2
• 07630030889820: MyKnee MIS FemDisCutBl-CT-GMK-RM-#1
• 07630030889813: MyKnee MIS FemDisCutBl-CT-GMK-LM-#7
• 07630030889790: MyKnee MIS FemDisCutBl-CT-GMK-LM-#6
• 07630030889776: MyKnee MIS FemDisCutBl-CT-GMK-LM-#5
• 07630030889752: MyKnee MIS FemDisCutBl-CT-GMK-LM-#4
• 07630030889738: MyKnee MIS FemDisCutBl-CT-GMK-LM-#3
• 07630030889714: MyKnee MIS FemDisCutBl-CT-GMK-LM-#2
• 07630030889691: MyKnee MIS FemDisCutBl-CT-GMK-LM-#1
• 07630030868535: MyKnee MIS FemDisCutBl-MRI-GMK-RM-#5+
• 07630030868511: MyKnee MIS FemDisCutBl-MRI-GMK-RM-#4+
• 07630030868498: MyKnee MIS FemDisCutBl-MRI-GMK-RM-#3+
• 07630030868399: MyKnee MIS FemDisCutBl-MRI-GMK-LM-#4+
• 07630030868375: MyKnee MIS FemDisCutBl-MRI-GMK-LM-#3+
• 07630030868351: MyKnee MIS FemDisCutBl-MRI-GMK-LM-#2+
• 07630030866517: MyKnee MIS FemDisCutBl-CT-GMK-RM-#6+
• 07630030866494: MyKnee MIS FemDisCutBl-CT-GMK-RM-#5+
• 07630030866470: MyKnee MIS FemDisCutBl-CT-GMK-RM-#4+
• 07630030866456: MyKnee MIS FemDisCutBl-CT-GMK-RM-#3+
• 07630030866432: MyKnee MIS FemDisCutBl-CT-GMK-RM-#2+
• 07630030866418: MyKnee MIS FemDisCutBl-CT-GMK-RM-#1+
• 07630030866395: MyKnee MIS FemDisCutBl-CT-GMK-LM-#6+
• 07630030866371: MyKnee MIS FemDisCutBl-CT-GMK-LM-#5+
• 07630030866357: MyKnee MIS FemDisCutBl-CT-GMK-LM-#4+
• 07630030866333: MyKnee MIS FemDisCutBl-CT-GMK-LM-#3+
• 07630030866319: MyKnee MIS FemDisCutBl-CT-GMK-LM-#2+
• 07630030866296: MyKnee MIS FemDisCutBl-CT-GMK-LM-#1+
• 07630030889936: MyKnee MIS FemDisCutBl-CT-GMK-RM-#6+
• 07630030889912: MyKnee MIS FemDisCutBl-CT-GMK-RM-#5+
• 07630030889899: MyKnee MIS FemDisCutBl-CT-GMK-RM-#4+
• 07630030889875: MyKnee MIS FemDisCutBl-CT-GMK-RM-#3+
• 07630030889851: MyKnee MIS FemDisCutBl-CT-GMK-RM-#2+
• 07630030889837: MyKnee MIS FemDisCutBl-CT-GMK-RM-#1+
• 07630030889806: MyKnee MIS FemDisCutBl-CT-GMK-LM-#6+
• 07630030889783: MyKnee MIS FemDisCutBl-CT-GMK-LM-#5+
• 07630030889769: MyKnee MIS FemDisCutBl-CT-GMK-LM-#4+
• 07630030889745: MyKnee MIS FemDisCutBl-CT-GMK-LM-#3+
• 07630030889721: MyKnee MIS FemDisCutBl-CT-GMK-LM-#2+
• 07630030889707: MyKnee MIS FemDisCutBl-CT-GMK-LM-#1+
• 07630030868405: MyKnee MIS FemDisCutBl-MRI-GMK-LM-#4+ ST
• 07630030866524: MyKnee MIS FemDisCutBl-CT-GMK-RM-#6+ ST
• 07630030866500: MyKnee MIS FemDisCutBl-CT-GMK-RM-#5+ ST
• 07630030866487: MyKnee MIS FemDisCutBl-CT-GMK-RM-#4+ ST
• 07630030866463: MyKnee MIS FemDisCutBl-CT-GMK-RM-#3+ ST
• 07630030866449: MyKnee MIS FemDisCutBl-CT-GMK-RM-#2+ ST