3DMetal Tibial Cones

GUDID 07630030884061

Centred XS H25

Medacta International SA

Knee arthroplasty wedge

• Primary Device ID: 07630030884061
• NIH Device Record Key: 45c4269b-bec5-4a80-9458-92ef4c86054f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DMetal Tibial Cones
• Version Model Number: 02.07.CXS25
• 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	07630030884061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170149

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: 2017-08-24

On-Brand Devices [3DMetal Tibial Cones]

• 07630030884146: Eccentric L H25
• 07630030884139: Eccentric M H25
• 07630030884122: Eccentric S H25
• 07630030884115: Eccentric S H20
• 07630030884108: Centred L H25
• 07630030884092: Centred M H25
• 07630030884085: Centred S H25
• 07630030884078: Centred S H20
• 07630030884061: Centred XS H25
• 07630030884054: Centred XS H20