E-XPE Patella 2403-5010

GUDID 04719872149958

E-XPE Patella, small, Ø22mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04719872149958
• NIH Device Record Key: a87ca235-4949-44ec-9a3e-05f3c1f0407c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-XPE Patella
• Version Model Number: 2403-5010
• Catalog Number: 2403-5010
• 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	04719872149958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161705

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, 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: 2018-07-31
• Device Publish Date: 2017-03-24

On-Brand Devices [E-XPE Patella]

• 04719872149989: E-XPE Patella, X-large Ø32mm
• 04719872149972: E-XPE Patella, large Ø28mm
• 04719872149965: E-XPE Patella, medium Ø25mm
• 04719872149958: E-XPE Patella, small, Ø22mm