Medial Rotation Knee 156-830

GUDID 05055455504868

Medial Rotation Knee Patella 30mm

MATORTHO LTD

Polyethylene patella prosthesis

• Primary Device ID: 05055455504868
• NIH Device Record Key: 85ef0b1e-3d8e-4784-8653-da1b3112ca8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medial Rotation Knee
• Version Model Number: 156-830
• Catalog Number: 156-830
• Company DUNS: 216819863
• Company Name: MATORTHO LTD
• 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	05055455504868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020214

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-12

On-Brand Devices [Medial Rotation Knee]

• 05055455504882: Medial Rotation Knee Patella Reduced Thickness 25mm
• 05055455504875: Medial Rotation Knee Patella Reduced Thickness 20mm
• 05055455504868: Medial Rotation Knee Patella 30mm
• 05055455503984: Medial Rotation Knee Right Tibial Insert Size 3 18mm
• 05055455503977: Medial Rotation Knee Right Tibial Insert Size 3 15.5mm
• 05055455503960: Medial Rotation Knee Right Tibial Insert Size 3 13mm
• 05055455503953: Medial Rotation Knee Right Tibial Insert Size 3 10.5mm
• 05055455503939: Medial Rotation Knee Right Tibial Insert Size 2 18mm
• 05055455503922: Medial Rotation Knee Right Tibial Insert Size 2 15.5mm
• 05055455503915: Medial Rotation Knee Right Tibial Insert Size 2 13mm
• 05055455503908: Medial Rotation Knee Right Tibial Insert Size 2 10.5mm
• 05055455503885: Medial Rotation Knee Right Tibial Insert Size 1 18mm
• 05055455503878: Medial Rotation Knee Right Tibial Insert Size 1 15.5mm
• 05055455503861: Medial Rotation Knee Right Tibial Insert Size 1 13mm
• 05055455503854: Medial Rotation Knee Right Tibial Insert Size 1 10.5mm
• 05055455503830: Medial Rotation Knee Left Tibial Insert Size 3 18mm
• 05055455503823: Medial Rotation Knee Left Tibial Insert Size 3 15.5mm
• 05055455503816: Medial Rotation Knee Left Tibial Insert Size 3 13mm
• 05055455503809: Medial Rotation Knee Left Tibial Insert Size 3 10.5mm
• 05055455503786: Medial Rotation Knee Left Tibial Insert Size 2 18mm
• 05055455503779: Medial Rotation Knee Left Tibial Insert Size 2 15.5mm
• 05055455503762: Medial Rotation Knee Left Tibial Insert Size 2 13mm
• 05055455503755: Medial Rotation Knee Left Tibial Insert Size 2 10.5mm
• 05055455503731: Medial Rotation Knee Left Tibial Insert Size 1 18mm
• 05055455503724: Medial Rotation Knee Left Tibial Insert Size 1 15.5mm
• 05055455503717: Medial Rotation Knee Left Tibial Insert Size 1 13mm
• 05055455503700: Medial Rotation Knee Left Tibial Insert Size 1 10.5mm
• 05055455503687: Medial Rotation Knee Tibia Metal Back T5 80 Stem
• 05055455503670: Medial Rotation Knee Tibia Metal Back T4 80 Stem
• 05055455503663: Medial Rotation Knee Tibia Metal Back T3 80 Stem
• 05055455503656: Medial Rotation Knee Tibia Metal Back T2 80 Stem
• 05055455503649: Medial Rotation Knee Tibia Metal Back T1 80 Stem
• 05055455503632: Medial Rotation Knee Tibia Metal Back T3 50 Stem
• 05055455503625: Medial Rotation Knee Tibia Metal Back T2 50 Stem
• 05055455503618: Medial Rotation Knee Tibia Metal Back T1 50 Stem
• 05055455503489: Medial Rotation Knee Femoral Component Pegged Right F5
• 05055455503472: Medial Rotation Knee Femoral Component Pegged Right F4
• 05055455503465: Medial Rotation Knee Femoral Component Pegged Right F3
• 05055455503458: Medial Rotation Knee Femoral Component Pegged Right F2
• 05055455503441: Medial Rotation Knee Femoral Component Pegged Right F1
• 05055455503434: Medial Rotation Knee Femoral Component Pegged Right F0
• 05055455503427: Medial Rotation Knee Femoral Component Pegged Left F5
• 05055455503410: Medial Rotation Knee Femoral Component Pegged Left F4
• 05055455503403: Medial Rotation Knee Femoral Component Pegged Left F3
• 05055455503397: Medial Rotation Knee Femoral Component Pegged Left F2
• 05055455503380: Medial Rotation Knee Femoral Component Pegged Left F1
• 05055455503373: Medial Rotation Knee Femoral Component Pegged Left F0