U1 Total Hip System 1403-6060

GUDID 04719872168355

U2 Acetabular cup liner trial, ID28mm, 10°×60mm

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: 04719872168355
• NIH Device Record Key: dd08fe23-a4ce-491e-9fc0-878b00dc8b4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Total Hip System
• Version Model Number: 1403-6060
• Catalog Number: 1403-6060
• 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	04719872168355 [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

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

[04719872168355]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

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