"UNITED" USTAR II Hip System

GUDID 04719872148173

Proximal Femoral Component, RHS, left

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04719872148173
• NIH Device Record Key: c4e117dd-7b25-4b46-92df-1424f6b7e4f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "UNITED" USTAR II Hip System
• Version Model Number: 1115-9110
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: service@uoc.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872148173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190100

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-03
• Device Publish Date: 2020-02-24

On-Brand Devices ["UNITED" USTAR II Hip System]

• 04719872154006: Press-Fit Straight Stem, RHS Ti plasma Spray Ø17×200mm
• 04719872153993: Press-Fit Straight Stem, RHS Ti plasma Spray Ø15×200mm
• 04719872153986: Press-Fit Straight Stem, RHS Ti plasma Spray Ø13×200mm
• 04719872153979: Press-Fit Straight Stem, RHS Ti plasma Spray Ø11×200mm
• 04719872153962: Press-Fit Straight Stem, RHS Ti plasma Spray Ø17×150mm
• 04719872153955: Press-Fit Straight Stem, RHS Ti plasma Spray Ø15×150mm
• 04719872153948: Press-Fit Straight Stem, RHS Ti plasma Spray Ø13×150mm
• 04719872153931: Press-Fit Straight Stem, RHS Ti plasma Spray Ø11×150mm
• 04719872153924: Press-Fit Curved Stem, RHS Ti plasma Spray Ø17×200mm
• 04719872153917: Press-Fit Curved Stem, RHS Ti plasma Spray Ø15×200mm
• 04719872153900: Press-Fit Curved Stem, RHS Ti plasma Spray Ø13×200mm
• 04719872153894: Press-Fit Curved Stem, RHS Ti plasma Spray Ø11×200mm
• 04719872153887: Press-Fit Curved Stem, RHS Ti plasma Spray Ø17×150mm
• 04719872153870: Press-Fit Curved Stem, RHS Ti plasma Spray Ø15×150mm
• 04719872153863: Press-Fit Curved Stem, RHS Ti plasma Spray Ø13×150mm
• 04719872149866: Press-Fit Curved Stem, RHS Ti plasma Spray Ø11×150mm
• 04719872148180: Proximal Femoral Component, RHS, right
• 04719872148173: Proximal Femoral Component, RHS, left
• 04711605584197: Trochanteric claw
• 04711605584180: Proximal femoral component, RHS, low profile
• 04711605584173: Proximal femoral component, RHS, low profile