U2 tibial baseplate, cemented 2203-3020

GUDID 04712602346030

U2 Tibial baseplate, cemented, #2

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602346030
• NIH Device Record Key: e46a3c9b-f313-4afb-b4de-f02f5018fc5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 tibial baseplate, cemented
• Version Model Number: 2203-3020
• Catalog Number: 2203-3020
• 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	04712602346030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051640

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: 2018-07-13
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 tibial baseplate, cemented]

• 04712602346078: U2 Tibial baseplate, cemented, #6
• 04712602346061: U2 Tibial baseplate, cemented, #5
• 04712602346054: U2 Tibial baseplate, cemented, #4
• 04712602346047: U2 Tibial baseplate, cemented, #3
• 04712602346030: U2 Tibial baseplate, cemented, #2
• 04712602346023: U2 Tibial baseplate, cemented, #1