UKNEE Tibial baseplate, porous coated 2201-1030

GUDID 04712602345866

UKNEE Tibial baseplate, porous coated, medium

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602345866
• NIH Device Record Key: ddbe5760-20fc-4d8e-b250-b9c2a4756f53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE Tibial baseplate, porous coated
• Version Model Number: 2201-1030
• Catalog Number: 2201-1030
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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

Customer Support Contacts

• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602345866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021657

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: 4
• Public Version Date: 2018-07-12
• Device Publish Date: 2015-10-24

On-Brand Devices [UKNEE Tibial baseplate, porous coated]

• 04712602345897: UKNEE Tibial baseplate, porous coated, XX-large
• 04712602345880: UKNEE Tibial baseplate, porous coated, X-large
• 04712602345873: UKNEE Tibial baseplate, porous coated, large
• 04712602345866: UKNEE Tibial baseplate, porous coated, medium
• 04712602345859: UKNEE Tibial baseplate, porous coated, small
• 04712602345842: UKNEE Tibial baseplate, porous coated, X-small