MyKnee UNI-ST

GUDID 07630030855306

MyKnee UNI Tibia Bone Model LM - STERILE

Medacta International SA

Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 07630030855306
• NIH Device Record Key: da8797ad-00e1-40dc-b0a1-8295d183054b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee UNI-ST
• Version Model Number: 4.9330S
• 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	07630030855306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231037

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [MyKnee UNI-ST]

• 07630345774453: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#6-7-8 ST
• 07630345774446: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#6-7-8
• 07630345774439: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#5 ST
• 07630345774422: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#5
• 07630345774415: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#4 ST
• 07630345774408: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#4
• 07630345774392: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#3 ST
• 07630345774385: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#3
• 07630345774378: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#1-2 ST
• 07630345774361: MyKnee UNI TibCutBl ShimTech-MRI-GMK- RM -#1-2
• 07630345774354: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#6-7-8 ST
• 07630345774347: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#6-7-8
• 07630345774330: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#5 ST
• 07630345774323: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#5
• 07630345774316: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#4 ST
• 07630345774309: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#4
• 07630345774293: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#3 ST
• 07630345774286: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#3
• 07630345774279: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#1-2 ST
• 07630345774262: MyKnee UNI TibCutBl ShimTech-MRI-GMK- LM -#1-2
• 07630345774255: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#6-7-8 ST
• 07630345774248: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#6-7-8
• 07630345774231: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#5 ST
• 07630345774224: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#5
• 07630345774217: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#4 ST
• 07630345774200: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#4
• 07630345774194: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#3 ST
• 07630345774187: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#3
• 07630345774170: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#1-2 ST
• 07630345774163: MyKnee UNI TibCutBl ShimTech-CT-GMK- RM -#1-2
• 07630345774156: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#6-7-8 ST
• 07630345774149: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#6-7-8
• 07630345774132: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#5 ST
• 07630345774125: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#5
• 07630345774118: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#4 ST
• 07630345774101: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#4
• 07630345774095: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#3 ST
• 07630345774088: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#3
• 07630345774071: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#1-2 ST
• 07630345774064: MyKnee UNI TibCutBl ShimTech-CT-GMK- LM -#1-2
• 07630030855306: MyKnee UNI Tibia Bone Model LM - STERILE