XPE Tibial Insert, PS 2303-3621

GUDID 04712771484526

XPE Tibial Insert, PS, #2, 9mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712771484526
• NIH Device Record Key: c9ede5dd-6c12-439d-b968-dbc43b573086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPE Tibial Insert, PS
• Version Model Number: 2303-3621
• Catalog Number: 2303-3621
• 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	04712771484526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103733

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 [XPE Tibial Insert, PS]

• 04712771505535: XPE Tibial insert, PS, #7, 18mm
• 04712771505528: XPE Tibial insert, PS, #7, 15mm
• 04712771505511: XPE Tibial insert, PS, #7, 13mm
• 04712771505504: XPE Tibial insert, PS, #7, 11mm
• 04712771505498: XPE Tibial insert, PS, #7, 9mm
• 04712771484762: XPE Tibial Insert, PS, #6, 18mm
• 04712771484755: XPE Tibial Insert, PS, #6, 15mm
• 04712771484748: XPE Tibial Insert, PS, #6, 13mm
• 04712771484731: XPE Tibial Insert, PS, #6, 11mm
• 04712771484724: XPE Tibial Insert, PS, #6, 9mm
• 04712771484717: XPE Tibial Insert, PS, #5, 18mm
• 04712771484700: XPE Tibial Insert, PS, #5, 15mm
• 04712771484694: XPE Tibial Insert, PS, #5, 13mm
• 04712771484687: XPE Tibial Insert, PS, #5, 11mm
• 04712771484670: XPE Tibial Insert, PS, #5, 9mm
• 04712771484663: XPE Tibial Insert, PS, #4, 18mm
• 04712771484656: XPE Tibial Insert, PS, #4, 15mm
• 04712771484649: XPE Tibial Insert, PS, #4, 13mm
• 04712771484632: XPE Tibial Insert, PS, #4, 11mm
• 04712771484625: XPE Tibial Insert, PS, #4, 9mm
• 04712771484618: XPE Tibial Insert, PS, #3, 18mm
• 04712771484601: XPE Tibial Insert, PS, #3, 15mm
• 04712771484595: XPE Tibial Insert, PS, #3, 13mm
• 04712771484588: XPE Tibial Insert, PS, #3, 11mm
• 04712771484571: XPE Tibial Insert, PS, #3, 9mm
• 04712771484564: XPE Tibial Insert, PS, #2, 18mm
• 04712771484557: XPE Tibial Insert, PS, #2, 15mm
• 04712771484540: XPE Tibial Insert, PS, #2, 13mm
• 04712771484533: XPE Tibial Insert, PS, #2, 11mm
• 04712771484526: XPE Tibial Insert, PS, #2, 9mm
• 04712771484519: XPE Tibial Insert, PS, #1, 18mm
• 04712771484502: XPE Tibial Insert, PS, #1, 15mm
• 04712771484496: XPE Tibial Insert, PS, #1, 13mm
• 04712771484489: XPE Tibial Insert, PS, #1, 11mm
• 04712771484472: XPE Tibial Insert, PS, #1, 9mm
• 04711605576277: XPE Tibial insert, PS, #7, 17mm
• 04711605576260: XPE Tibial insert, PS, #7, 16mm
• 04711605576253: XPE Tibial insert, PS, #7, 14mm
• 04711605576246: XPE Tibial insert, PS, #7, 12mm
• 04711605576239: XPE Tibial insert, PS, #7, 10mm
• 04711605576222: XPE Tibial insert, PS, #6, 17mm
• 04711605576215: XPE Tibial insert, PS, #6, 16mm
• 04711605576208: XPE Tibial insert, PS, #6, 14mm
• 04711605576192: XPE Tibial insert, PS, #6, 12mm
• 04711605576185: XPE Tibial insert, PS, #6, 10mm
• 04711605576178: XPE Tibial insert, PS, #5, 17mm
• 04711605576161: XPE Tibial insert, PS, #5, 16mm
• 04711605576154: XPE Tibial insert, PS, #5, 14mm
• 04711605576147: XPE Tibial insert, PS, #5, 12mm
• 04711605576130: XPE Tibial insert, PS, #5, 10mm