E-XPE Patellar, on set, 3 pegs 2403-5250

GUDID 04719872149927

E-XPE Patellar, on set, 3 pegs, X-large, Ø38 mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04719872149927
• NIH Device Record Key: 4c70236d-72d7-478f-8a54-9f2a55e3c427
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-XPE Patellar, on set, 3 pegs
• Version Model Number: 2403-5250
• Catalog Number: 2403-5250
• 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	04719872149927 [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 Patellar, on set, 3 pegs]

• 04719872149941: E-XPE Patellar, on set, 3 pegs, E-large, Ø44 mm
• 04719872149934: E-XPE Patellar, on set, 3 pegs, XX-large, Ø41 mm
• 04719872149927: E-XPE Patellar, on set, 3 pegs, X-large, Ø38 mm
• 04719872149910: E-XPE Patellar, on set, 3 pegs, large, Ø35 mm
• 04719872149903: E-XPE Patellar, on set, 3 pegs, medium,Ø32 mm
• 04719872149897: E-XPE Patellar, on set, 3 pegs, small, Ø29 mm
• 04719872149880: E-XPE Patellar, on set, 3 pegs, X-small, Ø26 mm