U1 Hip System 1201-2428

GUDID 04719872159490

Femoral head trial φ28mm, +5mm

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial

• Primary Device ID: 04719872159490
• NIH Device Record Key: c86d8b57-1b08-4921-a895-d15cc1b67dfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System
• Version Model Number: 1201-2428
• Catalog Number: 1201-2428
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872159490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022520

FDA Product Code

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

Sterilization

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

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

[04719872159490]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

On-Brand Devices [U1 Hip System]

• 04719872178972: Head Trial φ26mm X-Long (+9mm)
• 04719872178965: Head Trial φ26mm Long (+6mm)
• 04719872178958: Head Trial φ26mm medium (+3mm)
• 04719872178941: Head Trial φ26mm Standard (+0mm)
• 04719872159797: Femoral head trial φ36mm, +10mm
• 04719872159551: Femoral head trial, φ36mm, +5mm
• 04719872159537: Femoral head trial φ32mm, +5mm
• 04719872159490: Femoral head trial φ28mm, +5mm
• 04719872159476: Femoral head trial, φ26mm, +3mm
• 04719872159377: Femoral head trial φ36mm, +0mm
• 04719872159346: Femoral head trial φ32mm, +0mm