GMK-Revision/Hinge Total Knee System

GUDID 07630030877032

Screwed Tibial Augmentation # 5/15 mm (LM/RL)

Medacta International SA

Knee arthroplasty wedge

• Primary Device ID: 07630030877032
• NIH Device Record Key: 491458cc-4a33-4126-8bc2-3baae579d5cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK-Revision/Hinge Total Knee System
• Version Model Number: 02.09.TA515LMRL
• 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	07630030877032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172347

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: 2017-11-10

On-Brand Devices [GMK-Revision/Hinge Total Knee System]

• 07630030888977: Femoral Augmentation distal # 6/20 mm
• 07630030888960: Femoral Augmentation distal # 6/16 mm
• 07630030888953: Femoral Augmentation distal # 5/20 mm
• 07630030888946: Femoral Augmentation distal # 5/16 mm
• 07630030888939: Femoral Augmentation distal # 4/20 mm
• 07630030888922: Femoral Augmentation distal # 4/16 mm
• 07630030888915: Femoral Augmentation distal # 3/20 mm
• 07630030888908: Femoral Augmentation distal # 3/16 mm
• 07630030888892: Femoral Augmentation distal # 2/20 mm
• 07630030888885: Femoral Augmentation distal # 2/16 mm
• 07630030888878: Femoral Augmentation distal # 1/20 mm
• 07630030888861: Femoral Augmentation distal # 1/16 mm
• 07630030885501: Femoral Augmentation distal # 6/12 mm
• 07630030885495: Femoral Augmentation distal # 5/12 mm
• 07630030885488: Femoral Augmentation distal # 4/12 mm
• 07630030885129: Femoral Augmentation distal # 3/12 mm
• 07630030879524: UC Fixed tibial insert #6/26 mm
• 07630030879517: UC Fixed tibial insert #6/23 mm
• 07630030879500: UC Fixed tibial insert #6/20 mm
• 07630030879494: UC Fixed tibial insert #6/17 mm
• 07630030879487: UC Fixed tibial insert #6/14 mm
• 07630030879470: UC Fixed tibial insert #6/12 mm
• 07630030879456: UC Fixed tibial insert #5/26 mm
• 07630030879449: UC Fixed tibial insert #5/23 mm
• 07630030879432: UC Fixed tibial insert #5/20 mm
• 07630030879425: UC Fixed tibial insert #5/17 mm
• 07630030879418: UC Fixed tibial insert #5/14 mm
• 07630030879401: UC Fixed tibial insert #5/12 mm
• 07630030879388: UC Fixed tibial insert #4/26 mm
• 07630030879371: UC Fixed tibial insert #4/23 mm
• 07630030879364: UC Fixed tibial insert #4/20 mm
• 07630030879357: UC Fixed tibial insert #4/17 mm
• 07630030879340: UC Fixed tibial insert #4/14 mm
• 07630030879333: UC Fixed tibial insert #4/12 mm
• 07630030879319: UC Fixed tibial insert #3/26 mm
• 07630030879302: UC Fixed tibial insert #3/23 mm
• 07630030879296: UC Fixed tibial insert #3/20 mm
• 07630030879289: UC Fixed tibial insert #3/17 mm
• 07630030879272: UC Fixed tibial insert #3/14 mm
• 07630030879265: UC Fixed tibial insert #3/12 mm
• 07630030879241: UC Fixed tibial insert #2/26 mm
• 07630030879234: UC Fixed tibial insert #2/23 mm
• 07630030879227: UC Fixed tibial insert #2/20 mm
• 07630030879210: UC Fixed tibial insert #2/17 mm
• 07630030879203: UC Fixed tibial insert #2/14 mm
• 07630030879197: UC Fixed tibial insert #2/12 mm
• 07630030879173: UC Fixed tibial insert #1/26 mm
• 07630030879166: UC Fixed tibial insert #1/23 mm
• 07630030879159: UC Fixed tibial insert #1/20 mm
• 07630030879142: UC Fixed tibial insert #1/17 mm