Femoral component, PSA type 2103-5230

GUDID 04712602345804

Femoral component, PSA type, #3,Right

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602345804
• NIH Device Record Key: a748864a-f521-4047-8287-ab08ba4c99ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral component, PSA type
• Version Model Number: 2103-5230
• Catalog Number: 2103-5230
• 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	04712602345804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082424

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: 2018-07-18
• Device Publish Date: 2015-10-24

On-Brand Devices [Femoral component, PSA type]

• 04712602345835: Femoral component, PSA type, #6,Right
• 04712602345828: Femoral component, PSA type, #5,Right
• 04712602345811: Femoral component, PSA type, #4,Right
• 04712602345804: Femoral component, PSA type, #3,Right
• 04712602345798: Femoral component, PSA type, #2,Right
• 04712602345781: Femoral component, PSA type, #1,Right
• 04712602345774: Femoral component, PSA type, #6, left
• 04712602345767: Femoral component, PSA type, #5, left
• 04712602345750: Femoral component, PSA type, #4, left
• 04712602345743: Femoral component, PSA type, #3, left
• 04712602345736: Femoral component, PSA type, #2, left
• 04712602345729: Femoral component, PSA type, #1, left