MyKnee PPS

GUDID 07630030897252

MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#4

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030897252
• NIH Device Record Key: 9d65d6f5-7f84-48b0-b394-7c14c67f8154
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee PPS
• Version Model Number: 8.2294
• 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	07630030897252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170106

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

[07630030897252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [MyKnee PPS]

• 07630030897788: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#7
• 07630030897740: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#6
• 07630030897702: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#5
• 07630030897665: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#4
• 07630030897627: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#3
• 07630030897580: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#2
• 07630030897542: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#1
• 07630030897528: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#7
• 07630030897481: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#6
• 07630030897443: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#5
• 07630030897405: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#4
• 07630030897368: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#3
• 07630030897320: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#2
• 07630030897283: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#1
• 07630030897276: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#6
• 07630030897269: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#5
• 07630030897252: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#4
• 07630030897245: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#3
• 07630030897238: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#2
• 07630030897221: MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#1
• 07630030897207: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#6
• 07630030897184: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#5
• 07630030897160: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#4
• 07630030897146: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#3
• 07630030897122: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#2
• 07630030897108: MyKnee PPS MIS TibCutBlock-MRI-GMK-LL-#1
• 07630030897085: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#6
• 07630030897061: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#5
• 07630030897047: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#4
• 07630030897023: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#3
• 07630030897009: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#2
• 07630030896989: MyKnee PPS MIS TibCutBlock-MRI-GMK-RM-#1
• 07630030896965: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#6
• 07630030896941: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#5
• 07630030896927: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#4
• 07630030896903: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#3
• 07630030896880: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#2
• 07630030896866: MyKnee PPS MIS TibCutBlock-MRI-GMK-LM-#1
• 07630030897757: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#6+
• 07630030897719: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#5+
• 07630030897672: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#4+
• 07630030897634: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#3+
• 07630030897597: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#2+
• 07630030897559: MyKnee PPS STD FemDisCutBlock-MRI-GMK-RM-#1+
• 07630030897498: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#6+
• 07630030897450: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#5+
• 07630030897412: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#4+
• 07630030897375: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#3+
• 07630030897337: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#2+
• 07630030897290: MyKnee PPS STD FemDisCutBlock-MRI-GMK-LM-#1+