U2™ Knee 2103-2170

GUDID 04719872162391

Femoral trial, CR, #7, left

UNITED ORTHOPEDIC CORP.

Knee femur prosthesis trial Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable Knee femur prosthesis trial, reusable

• Primary Device ID: 04719872162391
• NIH Device Record Key: 2725c41d-7c67-44d8-b833-22d19a52d73a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2™ Knee
• Version Model Number: 2103-2170
• Catalog Number: 2103-2170
• 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	04719872162391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140073

FDA Product Code

• OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

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

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

Moist Heat or Steam Sterilization

[04719872162391]

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: 2017-05-19

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