U1 Total Hip System 1403-6054

GUDID 04719872168324

U2 Acetabular cup liner trial, ID28mm, 10°×54mm

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872168324
• NIH Device Record Key: f5774e89-10c0-4acf-85e4-a7157250be52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Total Hip System
• Version Model Number: 1403-6054
• Catalog Number: 1403-6054
• 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	04719872168324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050262

FDA Product Code

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

Sterilization

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

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

[04719872168324]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-24
• Device Publish Date: 2022-06-16

On-Brand Devices [U1 Total Hip System]

• 04719872168171: Acetabular cup liner trial 44mm
• 04711605584388: Femoral sizer, anterior reference
• 04711605584166: Bipolar cap gauge
• 04711605583527: Femoral A/P chamfer cutting guide, #4.5
• 04711605583510: Femoral A/P chamfer cutting guide, #3.5
• 04711605583503: Femoral A/P chamfer cutting guide, #2.5
• 04711605583497: Femoral A/P chamfer cutting guide, #1.5
• 04719872168331: U2 Acetabular cup liner trial, ID28mm, 10°×56mm
• 04719872168324: U2 Acetabular cup liner trial, ID28mm, 10°×54mm
• 04719872168317: U2 Acetabular cup liner trial, ID28mm, 10°×52mm
• 04719872168300: U2 Acetabular cup liner trial, ID28mm, 10°×50mm
• 04719872168294: U2 Acetabular cup liner trial, ID28mm, 10°×48mm
• 04719872168287: U2 Acetabular cup liner trial, ID26mm, 10°×46mm
• 04719872168270: U2 Acetabular cup liner trial, ID26mm, 10°×44mm
• 04719872168362: U2 Acetabular cup liner trial, ID28mm, 10°×62mm
• 04719872168355: U2 Acetabular cup liner trial, ID28mm, 10°×60mm
• 04719872168348: U2 Acetabular cup liner trial, ID28mm, 10°×58mm