U2 Total Knee System (UDI 04719872176398)
Manufactured by United Orthopedic Corporation
Device Regulatory Overview
The U2 Total Knee System (Model/Catalog Number: 9403-3014) is a medical device manufactured by United Orthopedic Corporation. This product is indexed under FDA Product Code / Category Classification L091102 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral co...
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthropl...
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicate...
Technical Specifications
- Model Number
- 9403-3014
- Product Code / EMDN
- L091102
- Device Name
- Straight stem reamer, Ø14mm
- Database Sync Date
- 2026-08-09 16:29:26
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of U2 Total Knee System?
The registered manufacturer of record for U2 Total Knee System is United Orthopedic Corporation.
What is the Primary UDI-DI identifier for U2 Total Knee System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04719872176398.
What classification code is assigned to this device?
This device is registered under product classification code L091102.
Similar Classification Devices (L091102)
Other Devices by United Orthopedic Corporation
- → UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
- → U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
- → U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
- → USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm,PE25153209 - 9x150mm,PE25153113 - 13x125mm,PE25153111- 11x125mm,PE25153115 - 15x125mm,PE25153211 - 11x150mm, PE25153213 - 13x150mm,PE25153217 - 17x150mm,PE25153117 - 17x125mm,PE25153015 - 15x100mm,PE25153215 - 15x150mm
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