MyKnee R Pin Positioners

GUDID 07630971283497

MyKnee R TibPinPositioner-CT-GMK-L-#4

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630971283497
• NIH Device Record Key: 4e256837-c78b-4f8c-93fb-ad8d9accb996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyKnee R Pin Positioners
• Version Model Number: 17.1034
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630971283497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220705

FDA Product Code

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

Sterilization

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

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

[07630971283497]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-06

On-Brand Devices [MyKnee R Pin Positioners]

• 07630971283664: MyKnee R TibPinPositioner-CT-GMK-R-#6 ST
• 07630971283657: MyKnee R TibPinPositioner-CT-GMK-R-#6
• 07630971283640: MyKnee R TibPinPositioner-CT-GMK-R-#5 ST
• 07630971283633: MyKnee R TibPinPositioner-CT-GMK-R-#5
• 07630971283626: MyKnee R TibPinPositioner-CT-GMK-R-#4 ST
• 07630971283619: MyKnee R TibPinPositioner-CT-GMK-R-#4
• 07630971283602: MyKnee R TibPinPositioner-CT-GMK-R-#3 ST
• 07630971283596: MyKnee R TibPinPositioner-CT-GMK-R-#3
• 07630971283589: MyKnee R TibPinPositioner-CT-GMK-R-#2 ST
• 07630971283572: MyKnee R TibPinPositioner-CT-GMK-R-#2
• 07630971283565: MyKnee R TibPinPositioner-CT-GMK-R-#1 ST
• 07630971283558: MyKnee R TibPinPositioner-CT-GMK-R-#1
• 07630971283541: MyKnee R TibPinPositioner-CT-GMK-L-#6 ST
• 07630971283534: MyKnee R TibPinPositioner-CT-GMK-L-#6
• 07630971283527: MyKnee R TibPinPositioner-CT-GMK-L-#5 ST
• 07630971283510: MyKnee R TibPinPositioner-CT-GMK-L-#5
• 07630971283503: MyKnee R TibPinPositioner-CT-GMK-L-#4 ST
• 07630971283497: MyKnee R TibPinPositioner-CT-GMK-L-#4
• 07630971283480: MyKnee R TibPinPositioner-CT-GMK-L-#3 ST
• 07630971283473: MyKnee R TibPinPositioner-CT-GMK-L-#3
• 07630971283466: MyKnee R TibPinPositioner-CT-GMK-L-#2 ST
• 07630971283459: MyKnee R TibPinPositioner-CT-GMK-L-#2
• 07630971283442: MyKnee R TibPinPositioner-CT-GMK-L-#1 ST
• 07630971283435: MyKnee R TibPinPositioner-CT-GMK-L-#1
• 07630971283428: MyKnee R FemPinPositioner-CT-GMK-R-#6 ST
• 07630971283411: MyKnee R FemPinPositioner-CT-GMK-R-#6
• 07630971283404: MyKnee R FemPinPositioner-CT-GMK-R-#5 ST
• 07630971283398: MyKnee R FemPinPositioner-CT-GMK-R-#5
• 07630971283381: MyKnee R FemPinPositioner-CT-GMK-R-#4 ST
• 07630971283374: MyKnee R FemPinPositioner-CT-GMK-R-#4
• 07630971283367: MyKnee R FemPinPositioner-CT-GMK-R-#3 ST
• 07630971283350: MyKnee R FemPinPositioner-CT-GMK-R-#3
• 07630971283343: MyKnee R FemPinPositioner-CT-GMK-R-#2 ST
• 07630971283336: MyKnee R FemPinPositioner-CT-GMK-R-#2
• 07630971283329: MyKnee R FemPinPositioner-CT-GMK-R-#1 ST
• 07630971283312: MyKnee R FemPinPositioner-CT-GMK-R-#1
• 07630971283305: MyKnee R FemPinPositioner-CT-GMK-L-#6 ST
• 07630971283299: MyKnee R FemPinPositioner-CT-GMK-L-#6
• 07630971283282: MyKnee R FemPinPositioner-CT-GMK-L-#5 ST
• 07630971283275: MyKnee R FemPinPositioner-CT-GMK-L-#5
• 07630971283268: MyKnee R FemPinPositioner-CT-GMK-L-#4 ST
• 07630971283251: MyKnee R FemPinPositioner-CT-GMK-L-#4
• 07630971283244: MyKnee R FemPinPositioner-CT-GMK-L-#3 ST
• 07630971283237: MyKnee R FemPinPositioner-CT-GMK-L-#3
• 07630971283220: MyKnee R FemPinPositioner-CT-GMK-L-#2 ST
• 07630971283213: MyKnee R FemPinPositioner-CT-GMK-L-#2
• 07630971283206: MyKnee R FemPinPositioner-CT-GMK-L-#1 ST
• 07630971283190: MyKnee R FemPinPositioner-CT-GMK-L-#1