MyKnee LBS

GUDID 07630030895333

MyKnee DIS LBS FemCutBl_Ass-CT-GMK SPH-RM-#3 ST

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030895333
• NIH Device Record Key: 8610bbc0-ebaa-45c5-81ba-191e4f9bbf03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee LBS
• Version Model Number: 6.3623S
• 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	07630030895333 [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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [MyKnee LBS]

• 07630030854491: MyKnee LBS FemCutBL_Assem -MRI- GMK -LM- #1
• 07630030894367: MyKnee LBS FemCutBl_Ass-MRI-GMK SPHERE-RM-#6
• 07630030894305: MyKnee LBS FemCutBl_Ass-MRI-GMK SPHERE-RM-#3
• 07630030894213: MyKnee LBS FemCutBl_Ass-MRI-GMK SPHERE-LM-#5
• 07630030893292: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#5
• 07630030893278: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#4
• 07630030893254: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#3
• 07630030893216: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-RM-#1
• 07630030893209: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#7
• 07630030893186: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#6
• 07630030893162: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#5
• 07630030893148: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#4
• 07630030893124: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#3
• 07630030893100: MyKnee LBS FemCutBl_Ass-CT-GMK SPHERE-LM-#2
• 07630030890628: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#7
• 07630030890611: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#6
• 07630030890604: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#5
• 07630030890598: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#4
• 07630030890581: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#3
• 07630030890574: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#2
• 07630030890567: MyKnee LBS FemCutBl_Ass-CT-GMK-LM-#1
• 07630030873584: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#7
• 07630030873560: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#6
• 07630030873546: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#5
• 07630030873522: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#4
• 07630030873508: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#3
• 07630030873485: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-RM-#2
• 07630030873447: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#7
• 07630030873423: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#6
• 07630030873409: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#5
• 07630030873386: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#4
• 07630030873362: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#3
• 07630030873348: MyKnee LBS FemCutBl_Ass-CT-GMK SPH-LM-#2
• 07630030855030: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #7
• 07630030855016: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #6
• 07630030854996: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #5
• 07630030854972: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #4
• 07630030854958: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #3
• 07630030854934: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #2
• 07630030854910: MyKnee LBS FemCutBL_Assem -MRI- GMK -RL- #1
• 07630030854897: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #7
• 07630030854873: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #6
• 07630030854859: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #5
• 07630030854835: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #4
• 07630030854811: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #3
• 07630030854798: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #2
• 07630030854774: MyKnee LBS FemCutBL_Assem -MRI- GMK -LL- #1
• 07630030854750: MyKnee LBS FemCutBL_Assem -MRI- GMK -RM- #7
• 07630030854736: MyKnee LBS FemCutBL_Assem -MRI- GMK -RM- #6
• 07630030854712: MyKnee LBS FemCutBL_Assem -MRI- GMK -RM- #5