NextAR Knee Platform

GUDID 07630345731807

MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM-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 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: 07630345731807
• NIH Device Record Key: 2386bf21-4363-4e08-8bb8-294b919779ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR Knee Platform
• Version Model Number: 16.8020S
• 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	07630345731807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213751

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: 2022-03-22
• Device Publish Date: 2022-03-14

On-Brand Devices [NextAR Knee Platform ]

• 07630345731807: MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM-sterile
• 07630345731791: MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM
• 07630345731784: MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM-sterile
• 07630345731777: MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM
• 07630345731678: MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM-sterile
• 07630345731661: MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM
• 07630345731654: MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM-sterile
• 07630345731647: MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM