3DMetal Diaphyseal Femoral Cones

GUDID 07630971259218

3DMetal Diaphyseal Femoral Cone Size Large

Medacta International SA

Knee arthroplasty wedge

• Primary Device ID: 07630971259218
• NIH Device Record Key: de46ce70-e03b-40eb-a76c-293b7e953766
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DMetal Diaphyseal Femoral Cones
• Version Model Number: 02.07.FCL30
• 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	07630971259218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200075

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: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [3DMetal Diaphyseal Femoral Cones]

• 07630971259249: 3DMetal Diaphyseal Femoral Cone Size Extra Large
• 07630971259232: 3DMetal Diaphyseal Femoral Cone Size Small
• 07630971259225: 3DMetal Diaphyseal Femoral Cone Size Medium
• 07630971259218: 3DMetal Diaphyseal Femoral Cone Size Large