GMK

GUDID 07630971260986

Patella resurfacing # 2 E-Cross

Medacta International SA

Polyethylene patella prosthesis

• Primary Device ID: 07630971260986
• NIH Device Record Key: 86560fe7-1a82-487a-9caa-6dd95c298e06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK
• Version Model Number: 02.12.E002RP
• 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	07630971260986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202022

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [GMK ]

• 07630971261006: Patella resurfacing # 4 E-Cross
• 07630971260993: Patella resurfacing # 3 E-Cross
• 07630971260986: Patella resurfacing # 2 E-Cross
• 07630971260979: Patella resurfacing # 1 E-Cross