U2 Femoral component, CR, porous coated 2103-1110

GUDID 04712602345361

U2 Femoral component, CR, porous coated, #1, left

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712602345361
• NIH Device Record Key: 00f58aa3-2d55-43f2-8c76-496a75d5b1a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral component, CR, porous coated
• Version Model Number: 2103-1110
• Catalog Number: 2103-1110
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602345361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140075

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-13
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Femoral component, CR, porous coated]

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• 04712771506266: U2 Femoral component, CR, porous coated, #7, left
• 04712602345477: U2 Femoral component, CR, porous coated, #6, right
• 04712602345460: U2 Femoral component, CR, porous coated, #5, right
• 04712602345453: U2 Femoral component, CR, porous coated, #4, right
• 04712602345446: U2 Femoral component, CR, porous coated, #3, right
• 04712602345439: U2 Femoral component, CR, porous coated, #2, right
• 04712602345422: U2 Femoral component, CR, porous coated, #1, right
• 04712602345415: U2 Femoral component, CR, porous coated, #6, left
• 04712602345408: U2 Femoral component, CR, porous coated, #5, left
• 04712602345392: U2 Femoral component, CR, porous coated, #4, left
• 04712602345385: U2 Femoral component, CR, porous coated, #3, left
• 04712602345378: U2 Femoral component, CR, porous coated, #2, left
• 04712602345361: U2 Femoral component, CR, porous coated, #1, left