U2 Total Knee System 2703-6127

GUDID 04719872166382

Straight stem trial, PSA, φ21×100mm

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872166382
• NIH Device Record Key: d0d28a18-684a-4910-80af-045944a1aa79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Total Knee System
• Version Model Number: 2703-6127
• Catalog Number: 2703-6127
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872166382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131864

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[04719872166382]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-25

On-Brand Devices [U2 Total Knee System]

• 04719872178750: Tibial baseplate driver
• 04719872178163: U2 Knee AiO tibia and inset patella case
• 04719872178156: U2 Knee AiO tibia and onset patella case
• 04719872178149: U2 Knee AiO femur and reusable trial case
• 04719872178132: U2 Knee AiO femur and reusable trial case
• 04719872178125: U2 Knee AiO femur case
• 04719872178118: AiO Case
• 04719872178101: PSA Distal spacer caddy
• 04719872178095: U2 PSA Knee femoral offset case
• 04719872178064: PSA Case #3
• 04719872178026: U2 Knee size 7 case
• 04719872178019: U2 Knee MIS case
• 04719872177999: U2 Knee CMA case
• 04719872177982: U2 Knee case #4
• 04719872177975: U2 Knee case #3
• 04719872177968: Tibial insert trial case
• 04719872177951: U2 Knee case #2
• 04719872177944: U2 Knee case #1
• 04719872175353: U2 Knee MIS case
• 04719872175339: U2 Knee case #5
• 04719872174370: MIS femoral cutting guide, #1
• 04719872174332: Femoral IM alignment guide , 7°, right
• 04719872171348: Tibial insert trial, CR, plained, #0, 13mm
• 04719872171331: Tibial insert trial, CR, plained, #0, 11mm
• 04719872171324: Tibial insert trial, CR, plained, #0, 11mm
• 04719872171317: Tibial insert trial, CR, plained, #0, 9mm
• 04719872170693: Straight stem trial, PSA, Ø23×150mm
• 04719872170686: Straight stem trial, PSA, ψ21 x 150mm
• 04719872170440: Straight stem trial, PSA, φ23×75mm
• 04719872170433: Straight stem trial, PSA, φ21×75mm
• 04719872170198: Straight stem trial, PSA, φ22×100mm
• 04719872170129: Straight stem trial, PSA, φ24×75mm
• 04719872170112: Straight stem trial, PSA, φ22×75mm
• 04719872169000: Tibial insert trial, CR, plained, #1, 13mm
• 04719872168980: Tibial insert trial, CR, plained, #1, 11mm
• 04719872168966: Tibial insert trial, CR, plained, #1, 9mm
• 04719872168942: Tibial insert trial, CR, plained, #0, 18mm
• 04719872168935: Tibial insert trial, CR, plained, #0, 18mm
• 04719872168928: Tibial insert trial, CR, plained, #0, 15mm
• 04719872168911: Tibial insert trial, CR, plained, #0, 15mm
• 04719872168904: Tibial insert trial, CR, plained, #0, 13mm
• 04719872168898: Tibial insert trial, CR, plained, #0, 9mm
• 04719872168751: Tibial baseplate trial, #0
• 04719872167730: MIS femoral A/P chamfer cutting guide,＃5
• 04719872166399: Straight stem trial, PSA, φ23×100mm
• 04719872166382: Straight stem trial, PSA, φ21×100mm
• 04719872165279: Tibial insert trial, PS, #7, 18mm
• 04719872165255: Tibial insert trial, PS, #7, 15mm
• 04719872165231: Tibial insert trial, PS, #7, 13mm
• 04719872165217: Tibial insert trial, PS, #7, 11mm