GMK Hinge Total Knee System

GUDID 07630030825415

Femoral Component Left, size 2

Medacta International SA

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 07630030825415
• NIH Device Record Key: 55566ab9-b8bd-4ec4-84e7-3c617860a388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Hinge Total Knee System
• Version Model Number: 02.09.2602L
• 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	07630030825415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130299

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, 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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2014-11-18

On-Brand Devices [GMK Hinge Total Knee System]

• 07630030825767: Tibial Augmentation # 6/10mm
• 07630030825750: Tibial Augmentation # 6/5mm
• 07630030825743: Tibial Augmentation # 5/10mm
• 07630030825736: Tibial Augmentation # 5/5mm
• 07630030825729: Tibial Augmentation # 4/10mm
• 07630030825712: Tibial Augmentation # 4/5mm
• 07630030825705: Tibial Augmentation # 3/10mm
• 07630030825699: Tibial Augmentation # 3/5mm
• 07630030825682: Tibial Augmentation # 2/10mm
• 07630030825675: Tibial Augmentation # 2/5mm
• 07630030825668: Tibial Augmentation # 1/10mm
• 07630030825651: Tibial Augmentation # 1/5mm
• 07630030825644: Tibial Augmentation # 0/10mm
• 07630030825637: Tibial Augmentation # 0/5mm
• 07630030825620: Fixed tibial tray Right, size 6
• 07630030825613: Fixed tibial tray Left, size 6
• 07630030825606: Fixed tibial tray Right, size 5
• 07630030825590: Fixed tibial tray Left, size 5
• 07630030825583: Fixed tibial tray Right, size 4
• 07630030825576: Fixed tibial tray Left, size 4
• 07630030825569: Fixed tibial tray Right, size 3
• 07630030825552: Fixed tibial tray Left, size 3
• 07630030825545: Fixed tibial tray Right, size 2
• 07630030825538: Fixed tibial tray Left, size 2
• 07630030825521: Fixed tibial tray Right, size 1
• 07630030825514: Fixed tibial tray Left, size 1
• 07630030825507: Femoral Component Right, size 6
• 07630030825491: Femoral Component Left, size 6
• 07630030825484: Femoral Component Right, size 5
• 07630030825477: Femoral Component Left, size 5
• 07630030825460: Femoral Component Right, size 4
• 07630030825453: Femoral Component Left, size 4
• 07630030825446: Femoral Component Right, size 3
• 07630030825439: Femoral Component Left, size 3
• 07630030825422: Femoral Component Right, size 2
• 07630030825415: Femoral Component Left, size 2
• 07630030825408: Femoral Component Right, size 1
• 07630030825392: Femoral Component Left, size 1
• 07630030825385: Fixed tibial insert # 6/26mm
• 07630030825378: Fixed tibial insert # 6/23mm
• 07630030825361: Fixed tibial insert # 6/20mm
• 07630030825354: Fixed tibial insert # 6/17mm
• 07630030825347: Fixed tibial insert # 6/14mm
• 07630030825330: Fixed tibial insert # 6/12mm
• 07630030825316: Fixed tibial insert # 5/26mm
• 07630030825309: Fixed tibial insert # 5/23mm
• 07630030825293: Fixed tibial insert # 5/20mm
• 07630030825286: Fixed tibial insert # 5/17mm
• 07630030825279: Fixed tibial insert # 5/14mm
• 07630030825262: Fixed tibial insert # 5/12mm