U2 Knee Modular Disposable Trial 2104-2125

GUDID 04711605578950

Femoral trial set, #2.5, left

UNITED ORTHOPEDIC CORP.

Knee femur prosthesis trial

• Primary Device ID: 04711605578950
• NIH Device Record Key: 3953a21d-9063-4837-873e-5f805736b2fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Knee Modular Disposable Trial
• Version Model Number: 2104-2125
• Catalog Number: 2104-2125
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• 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
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605578950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120507

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-25

Devices Manufactured by UNITED ORTHOPEDIC CORP.

• 04719886903379 - U-Motion II: 2024-07-16 Cup impactor adaptor
• 04719886903249 - Resolve Modular Revision Stem: 2024-06-26 Resolve starter reamer
• 04719886903270 - Resolve Modular Revision Stem: 2024-06-26 Resolve taper reamer, Ø12×180mm
• 04719872142904 - Conformity Stem: 2024-06-25 Sharp broach, #1
• 04719872142911 - Conformity Stem: 2024-06-25 Sharp broach, #2
• 04719872142928 - Conformity Stem: 2024-06-25 Sharp broach, #3
• 04719872142935 - Conformity Stem: 2024-06-25 Sharp broach, #4
• 04719872142942 - Conformity Stem: 2024-06-25 Sharp broach, #5