U1 Hip System 1201-2132-RA

GUDID 04719872159346

Femoral head trial φ32mm, +0mm

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial Femoral head prosthesis trial

• Primary Device ID: 04719872159346
• NIH Device Record Key: b348f764-02ea-44b6-8f54-335a0e6cef7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System
• Version Model Number: 1201-2132-RA
• Catalog Number: 1201-2132-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872159346 [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

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

Moist Heat or Steam Sterilization

[04719872159346]

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