MyKnee NextAR Tibial Distal Cutting Block Efficiency

GUDID 07630971271814

MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #6 - STERILE

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation 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: 07630971271814
• NIH Device Record Key: 14ee3b9a-4f38-4f2e-96fb-2700a1ad347e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee NextAR Tibial Distal Cutting Block Efficiency
• Version Model Number: 15.1246S
• 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	07630971271814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193559

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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [MyKnee NextAR Tibial Distal Cutting Block Efficiency]

• 07630971273924: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #6 - STERILE
• 07630971273917: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #6
• 07630971273900: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #5 - STERILE
• 07630971273894: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #5
• 07630971273887: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #4 - STERILE
• 07630971273870: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #4
• 07630971273863: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #3 - STERILE
• 07630971273856: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #3
• 07630971273849: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #2 - STERILE
• 07630971273832: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #2
• 07630971273825: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #1 - STERILE
• 07630971273818: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Right Medial - #1
• 07630971273801: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #6 - STERILE
• 07630971273795: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #6
• 07630971273788: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #5 - STERILE
• 07630971273771: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #5
• 07630971273764: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #4 - STERILE
• 07630971273757: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #4
• 07630971273740: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #3 - STERILE
• 07630971273733: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #3
• 07630971273726: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #2 - STERILE
• 07630971273719: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #2
• 07630971273702: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #1 - STERILE
• 07630971273696: MyKnee NEXTAR Tibia Distal Cutting Block - MRI - GMK – Left Medial - #1
• 07630971271814: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #6 - STERILE
• 07630971271807: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #6
• 07630971271791: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #5 - STERILE
• 07630971271784: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #5
• 07630971271777: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #4 - STERILE
• 07630971271760: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #4
• 07630971271753: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #3 - STERILE
• 07630971271746: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #3
• 07630971271739: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #2 - STERILE
• 07630971271722: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #2
• 07630971271715: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #1 - STERILE
• 07630971271708: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Right Medial - #1
• 07630971271692: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #6 - STERILE
• 07630971271685: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #6
• 07630971271678: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #5 - STERILE
• 07630971271661: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #5
• 07630971271654: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #4 - STERILE
• 07630971271647: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #4
• 07630971271630: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #3 - STERILE
• 07630971271623: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #3
• 07630971271616: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #2 - STERILE
• 07630971271609: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #2
• 07630971271593: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #1 - STERILE
• 07630971271586: MyKnee NEXTAR Tibia Distal Cutting Block - CT - GMK – Left Medial - #1