U2 Acetabular Components 1303-2060-RA

GUDID 04719872168065

Cup trial, φ60mm

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial

• Primary Device ID: 04719872168065
• NIH Device Record Key: ed416e2d-8522-4f03-bf7a-c7b889bd9e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Components
• Version Model Number: 1303-2060-RA
• Catalog Number: 1303-2060-RA
• 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: false
• 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: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872168065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111546

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

[04719872168065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-12
• Device Publish Date: 2022-07-04

On-Brand Devices [U2 Acetabular Components]

• 04719872177869: U2 Acetabular case
• 04719872177852: Acetabular MIS case
• 04719872173571: U2 Acetabular case
• 04719872173564: Screw set case
• 04719872173557: Acetabular MIS case
• 04719872173540: MIS set case
• 04719872173533: Cup reamer set case
• 04719872140153: Flexible drill, 75mm
• 04719872140146: Acetabular MIS case
• 04719872161271: XPE cup liner trial, ID 32mm, 10°x58mm
• 04719872161158: XPE cup liner trial, ID 28mm, 10°x58mm
• 04719872161561: Acetabular cup liner trial, ID 26mm, 10°×46mm
• 04719872161554: Acetabular cup liner trial, ID26mm, 10°×44mm
• 04719872168447: U2 Acetabular cup liner trial, ID26mm, 10°×62mm
• 04719872168430: U2 Acetabular cup liner trial, ID26mm, 10°×60mm
• 04719872168423: U2 Acetabular cup liner trial, ID26mm, 10°×58mm
• 04719872168416: U2 Acetabular cup liner trial, ID26mm, 10°×56mm
• 04719872168409: U2 Acetabular cup liner trial, ID26mm, 10°×54mm
• 04719872168393: U2 Acetabular cup liner trial, ID26mm, 10°×52mm
• 04719872168386: U2 Acetabular cup liner trial, ID26mm, 10°×50mm
• 04719872168379: U2 Acetabular cup liner trial, ID26mm, 10°×48mm
• 04719872168164: Cup trial, φ70mm
• 04719872168140: Cup trial, φ68mm
• 04719872168126: Cup trial, φ66mm
• 04719872168102: Cup trial, φ64mm
• 04719872168089: Cup trial, φ62mm
• 04719872168065: Cup trial, φ60mm
• 04719872168041: Cup trial, φ58mm
• 04719872168027: Cup trial, φ56mm
• 04719872168003: Cup trial, φ54mm
• 04719872167983: Cup trial, φ52mm
• 04719872167969: Cup trial, φ50mm
• 04719872167945: Cup trial, φ48mm
• 04719872167921: Cup trial, φ46mm
• 04719872167907: Cup trial, φ44mm
• 04719872167884: Cup trial, φ42mm