XPE Tibial insert, CR 2303-1675

GUDID 04712771505436

XPE Tibial insert, CR, #7, 18mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis
Primary Device ID04712771505436
NIH Device Record Key808f0f4b-ac85-4359-96d1-ccf826ad37c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPE Tibial insert, CR
Version Model Number2303-1675
Catalog Number2303-1675
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712771505436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-25
Device Publish Date2015-10-24

On-Brand Devices [XPE Tibial insert, CR]

04712771505436XPE Tibial insert, CR, #7, 18mm
04712771505429XPE Tibial insert, CR, #7, 15mm
04712771505412XPE Tibial insert, CR, #7, 13mm
04712771505405XPE Tibial insert, CR, #7, 11mm
04712771505399XPE Tibial insert, CR, #7, 9mm
04712771484465XPE Tibial Insert, CR, #6, 18mm
04712771484458XPE Tibial Insert, CR, #6, 15mm
04712771484441XPE Tibial Insert, CR, #6, 13mm
04712771484434XPE Tibial Insert, CR, #6, 11mm
04712771484427XPE Tibial Insert, CR, #6, 9mm
04712771484410XPE Tibial Insert, CR, #5, 18mm
04712771484403XPE Tibial Insert, CR, #5, 15mm
04712771484397XPE Tibial Insert, CR, #5, 13mm
04712771484380XPE Tibial Insert, CR, #5, 11mm
04712771484373XPE Tibial Insert, CR, #5, 9mm
04712771484366XPE Tibial Insert, CR, #4, 18mm
04712771484359XPE Tibial Insert, CR, #4, 15mm
04712771484342XPE Tibial Insert, CR, #4, 13mm
04712771484335XPE Tibial Insert, CR, #4, 11mm
04712771484328XPE Tibial Insert, CR, #4, 9mm
04712771484311XPE Tibial Insert, CR, #3, 18mm
04712771484304XPE Tibial Insert, CR, #3, 15mm
04712771484298XPE Tibial Insert, CR, #3, 13mm
04712771484281XPE Tibial Insert, CR, #3, 11mm
04712771484274XPE Tibial Insert, CR, #3, 9mm
04712771484267XPE Tibial Insert, CR, #2, 18mm
04712771484250XPE Tibial Insert, CR, #2, 15mm
04712771484243XPE Tibial Insert, CR, #2, 13mm
04712771484236XPE Tibial Insert, CR, #2, 11mm
04712771484229XPE Tibial Insert, CR, #2, 9mm
04712771484212XPE Tibial Insert, CR, #1, 18mm
04712771484205XPE Tibial Insert, CR, #1, 15mm
04712771484199XPE Tibial Insert, CR, #1, 13mm
04712771484182XPE Tibial Insert, CR, #1, 11mm
04712771484175XPE Tibial Insert, CR, #1, 9mm
04711605575874XPE Tibial insert, CR, #7, 17mm
04711605575867XPE Tibial insert, CR, #7, 16mm
04711605575850XPE Tibial insert, CR, #7, 14mm
04711605575843XPE Tibial insert, CR, #7, 12mm
04711605575836XPE Tibial insert, CR, #7, 10mm
04711605575829XPE Tibial insert, CR, #6, 17mm
04711605575812XPE Tibial insert, CR, #6, 16mm
04711605575805XPE Tibial insert, CR, #6, 14mm
04711605575799XPE Tibial insert, CR, #6, 12mm
04711605575782XPE Tibial insert, CR, #6, 10mm
04711605575775XPE Tibial insert, CR, #5, 17mm
04711605575768XPE Tibial insert, CR, #5, 16mm
04711605575751XPE Tibial insert, CR, #5, 14mm
04711605575744XPE Tibial insert, CR, #5, 12mm
04711605575737XPE Tibial insert, CR, #5, 10mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.