U2™ Knee 2203-4030-RB

GUDID 04719872168812

Tibial baseplate trial, #3

UNITED ORTHOPEDIC CORP.

Knee tibia prosthesis trial

• Primary Device ID: 04719872168812
• NIH Device Record Key: 17a2337a-cdab-4a28-8ae3-cf48031a17df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2™ Knee
• Version Model Number: 2203-4030-RB
• Catalog Number: 2203-4030-RB
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872168812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120507

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

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

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

[04719872168812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-06-02

On-Brand Devices [U2™ Knee]

• 04719872179320: Tibial baseplate impactor
• 04719872179313: Tibial baseplate impactor
• 04719872179306: PSA Tibial resection guide, 0°, right
• 04719872179290: PSA Tibial resection guide, 0°, left
• 04719872179283: Tibial drill guide
• 04719872178934: Tibial baseplate trial, #7
• 04719872178927: Tibial baseplate trial, #6
• 04719872178910: Tibial baseplate trial, #5
• 04719872178903: Tibial baseplate trial, #4
• 04719872178897: Tibial baseplate trial, #3
• 04719872178880: Tibial baseplate trial, #2
• 04719872178873: Tibial baseplate trial, #1
• 04719872178088: PSA Case #5
• 04719872178071: PSA Case #4
• 04719872178057: PSA Case #3
• 04719872178040: PSA Case #2
• 04719872178033: PSA Case #1
• 04719872178002: U2 Knee XUC case
• 04719872177609: Patellar stylus
• 04719872177593: Gap gauge, 18mm
• 04719872177586: Gap gauge, 17mm
• 04719872177579: Gap gauge, 14/16mm
• 04719872177562: Gap gauge, 13/15mm
• 04719872177555: Gap gauge, 10/12mm
• 04719872177548: Tibial stylus
• 04719872177531: Gap gauge, 9/11mm
• 04719872177524: Patellar reamer stopper
• 04719872177517: Patellar clamp ring, XL
• 04719872177500: Patellar clamp ring, L
• 04719872177494: Patellar clamp ring, M
• 04719872177487: Patellar clamp ring, S
• 04719872177470: Patellar cement clamp adapter
• 04719872177463: Patella clamp
• 04719872177456: Patella protector, 38mm
• 04719872177449: Patella protector, 32mm
• 04719872177432: Patella protector, 26mm
• 04719872177425: Slot attachment
• 04719872177418: APT component impactor
• 04719872177401: Tibial baseplate impactor
• 04719872177395: Patellar reamer, XL
• 04719872177388: Patellar reamer, L
• 04719872177371: Patellar reamer, M
• 04719872177364: Patellar reamer, S
• 04719872177357: On set patellar peg drill
• 04719872177340: Tibial drill, Ø14mm
• 04719872177333: On set patellar drill guide
• 04719872177326: On set patellar resection guide
• 04719872177319: On set patellar resection guide
• 04719872177302: Tibial EM alignment guide
• 04719872177296: Tibial drill guide