USTAR II Hip System 2215-4210

GUDID 04719872140016

USTAR II Proximal tibial trial, RHS, S

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872140016
• NIH Device Record Key: e419ae70-466b-4a79-956c-e3b56c68a7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USTAR II Hip System
• Version Model Number: 2215-4210
• Catalog Number: 2215-4210
• 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: service@uoc.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872140016 [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: true
• Device Is Sterile: false

[04719872140016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [USTAR II Hip System]

• 04719872140016: USTAR II Proximal tibial trial, RHS, S
• 04711605589987: USTAR II Proximal femoral trial, RHS, low profile, right
• 04711605589970: USTAR II Proximal femoral trial, RHS, low profile, left
• 04711605589963: USTAR II Proximal femoral trial, RHS, right
• 04711605589956: USTAR II Proximal femoral trial, RHS, left
• 04719872140207: USTAR II Press-fit stem barrel reamer
• 04719872141983: Resection template, proximal femur
• 04711605589727: Impactor base, proximal femur
• 04719886900354: USTAR II Proximal femoral trial, RHS, right
• 04719886900347: USTAR II Proximal femoral trial, RHS, left
• 04719886900330: USTAR II Proximal femoral trial, RHS, low profile, right
• 04719886900323: USTAR II Proximal femoral trial, RHS, low profile, left