XPE Tibial insert, PSA, LC 2303-5243

GUDID 04719872149637

XPE Tibial insert, PSA, LC, #4, 13mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04719872149637
• NIH Device Record Key: 4c9d961e-b8d6-49b2-9a05-443ab32d72a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPE Tibial insert, PSA, LC
• Version Model Number: 2303-5243
• Catalog Number: 2303-5243
• 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	04719872149637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161360

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: 2017-03-16

On-Brand Devices [XPE Tibial insert, PSA, LC]

• 04719872149842: XPE Tibial insert, PSA, LC, #6, 30mm
• 04719872149835: XPE Tibial insert, PSA, LC, #6, 25mm
• 04719872149828: XPE Tibial insert, PSA, LC, #6, 21mm
• 04719872149811: XPE Tibial insert, PSA, LC, #6, 18mm
• 04719872149804: XPE Tibial insert, PSA, LC, #6, 15mm
• 04719872149798: XPE Tibial insert, PSA, LC, #6, 13mm
• 04719872149781: XPE Tibial insert, PSA, LC, #6, 11mm
• 04719872149774: XPE Tibial insert, PSA, LC, #6, 9mm
• 04719872149767: XPE Tibial insert, PSA, LC, #5, 30mm
• 04719872149750: XPE Tibial insert, PSA, LC, #5, 25mm
• 04719872149743: XPE Tibial insert, PSA, LC, #5, 21mm
• 04719872149736: XPE Tibial insert, PSA, LC, #5, 18mm
• 04719872149729: XPE Tibial insert, PSA, LC, #5, 15mm
• 04719872149712: XPE Tibial insert, PSA, LC, #5, 13mm
• 04719872149705: XPE Tibial insert, PSA, LC, #5, 11mm
• 04719872149699: XPE Tibial insert, PSA, LC, #5, 9mm
• 04719872149682: XPE Tibial insert, PSA, LC, #4, 30mm
• 04719872149675: XPE Tibial insert, PSA, LC, #4, 25mm
• 04719872149668: XPE Tibial insert, PSA, LC, #4, 21mm
• 04719872149651: XPE Tibial insert, PSA, LC, #4, 18mm
• 04719872149644: XPE Tibial insert, PSA, LC, #4, 15mm
• 04719872149637: XPE Tibial insert, PSA, LC, #4, 13mm
• 04719872149620: XPE Tibial insert, PSA, LC, #4, 11mm
• 04719872149613: XPE Tibial insert, PSA, LC, #4, 9mm
• 04719872149606: XPE Tibial insert, PSA, LC, #3, 30mm
• 04719872149590: XPE Tibial insert, PSA, LC, #3, 25mm
• 04719872149583: XPE Tibial insert, PSA, LC, #3, 21mm
• 04719872149576: XPE Tibial insert, PSA, LC, #3, 18mm
• 04719872149569: XPE Tibial insert, PSA, LC, #3, 15mm
• 04719872149552: XPE Tibial insert, PSA, LC, #3, 13mm
• 04719872149545: XPE Tibial insert, PSA, LC, #3, 11mm
• 04719872149538: XPE Tibial insert, PSA, LC, #3, 9mm
• 04719872149521: XPE Tibial insert, PSA, LC, #2, 30mm
• 04719872149514: XPE Tibial insert, PSA, LC, #2, 25mm
• 04719872149507: XPE Tibial insert, PSA, LC, #2, 21mm
• 04719872149491: XPE Tibial insert, PSA, LC, #2, 18mm
• 04719872149484: XPE Tibial insert, PSA, LC, #2, 15mm
• 04719872149477: XPE Tibial insert, PSA, LC, #2, 13mm
• 04719872149460: XPE Tibial insert, PSA, LC, #2, 11mm
• 04719872149453: XPE Tibial insert, PSA, LC, #2, 9mm
• 04719872149446: XPE Tibial insert, PSA, LC, #1, 30mm
• 04719872149439: XPE Tibial insert, PSA, LC, #1, 25mm
• 04719872149422: XPE Tibial insert, PSA, LC, #1, 21mm
• 04719872149415: XPE Tibial insert, PSA, LC, #1, 18mm
• 04719872149408: XPE Tibial insert, PSA, LC, #1, 15mm
• 04719872149392: XPE Tibial insert, PSA, LC, #1, 13mm
• 04719872149385: XPE Tibial insert, PSA, LC, #1, 11mm
• 04719872149378: XPE Tibial insert, PSA, LC, #1, 9mm