"UNITED" USTAR II Knee System

GUDID 04719872148395

Segment part, 220mm

UNITED ORTHOPEDIC CORP.

Rotating hinged total knee prosthesis

• Primary Device ID: 04719872148395
• NIH Device Record Key: bd3e6f4c-ef2b-4c43-a009-6ed9b96fd757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "UNITED" USTAR II Knee System
• Version Model Number: 2915-1220
• 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	04719872148395 [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 Knee System ]

• 04719872154730: Cemented tibial stem, Ø9×145mm
• 04719872154709: Cemented tibial stem, Ø9×70mm
• 04719872154693: Cemented tibial stem, Ø9×20mm
• 04719872154686: Cemented tibial stem, Ø9×20mm
• 04719872154495: Cemented straight stem, RHS, non coated, Ø15×125mm
• 04719872154488: Cemented straight stem, RHS, non coated, Ø13×125mm
• 04719872154471: Cemented straight stem, RHS, non coated, Ø11×125mm
• 04719872154464: Cemented straight stem, RHS, non coated, Ø9×125mm
• 04719872154457: Cemented straight stem, RHS, Ø15×125mm
• 04719872154440: Cemented straight stem, RHS, Ø13×125mm
• 04719872154433: Cemented straight stem, RHS, Ø11×125mm
• 04719872154426: Cemented straight stem, RHS, Ø9×125mm
• 04719872154242: Tibial augment, #6, 15mm, right medial/left lateral
• 04719872154235: Tibial augment, #6, 15mm, left medial/right lateral
• 04719872154228: Tibial augment, #5, 15mm, right medial/left lateral
• 04719872154211: Tibial augment, #5, 15mm, left medial/right lateral
• 04719872154204: Tibial augment, #4, 15mm, right medial/left lateral
• 04719872154198: Tibial augment, #4, 15mm, left medial/right lateral
• 04719872154181: Tibial augment, #3, 15mm, right medial/left lateral
• 04719872154174: Tibial augment, #3, 15mm, left medial/right lateral
• 04719872154167: Tibial augment, #2, 15mm, right medial/left lateral
• 04719872154150: Tibial augment, #2, 15mm, left medial/right lateral
• 04719872154143: Tibial augment, #1, 15mm, right medial/left lateral
• 04719872154136: Tibial augment, #1, 15mm, left medial/right lateral
• 04719872154129: Tibial augment, #6, 10mm
• 04719872154112: Tibial augment, #6, 5mm
• 04719872154105: Tibial augment, #5, 10mm
• 04719872154099: Tibial augment, #5, 5mm
• 04719872154082: Tibial augment, #4, 10mm
• 04719872154075: Tibial augment, #4, 5mm
• 04719872154068: Tibial augment, #3, 10mm
• 04719872154051: Tibial augment, #3, 5mm
• 04719872154044: Tibial augment, #2, 10mm
• 04719872154037: Tibial augment, #2, 5mm
• 04719872154020: Tibial augment, #1, 10mm
• 04719872154013: Tibial augment, #1, 5mm
• 04719872153856: Cemented straight stem, RHS, non coated, Ø15×150mm
• 04719872153849: Cemented straight stem, RHS, non coated, Ø13×150mm
• 04719872153832: Cemented straight stem, RHS, non coated, Ø11×150mm
• 04719872153825: Cemented straight stem, RHS, non coated, Ø9×150mm
• 04719872153818: Cemented straight stem, RHS, non coated, Ø15×100mm
• 04719872153801: Cemented straight stem, RHS, non coated, Ø13×100mm
• 04719872153795: Cemented straight stem, RHS, non coated, Ø11×100mm
• 04719872153788: Cemented straight stem, RHS, non coated, Ø9×100mm
• 04719872153771: Cemented straight stem, RHS, Ø15×150mm
• 04719872153764: Cemented straight stem, RHS, Ø13×150mm
• 04719872153757: Cemented straight stem, RHS, Ø11×150mm
• 04719872153740: Cemented straight stem, RHS, Ø9×150mm
• 04719872153733: Cemented straight stem, RHS, Ø15×100mm
• 04719872153726: Cemented straight stem, RHS, Ø13×100mm