XPE Tibial insert, UC 2303-1439

GUDID 04711605576468

XPE Tibial insert, UC, #3, 16mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis
Primary Device ID04711605576468
NIH Device Record Key17d2e7f7-c116-477a-bc88-47163eb15dea
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPE Tibial insert, UC
Version Model Number2303-1439
Catalog Number2303-1439
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

Height16 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104711605576468 [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 Date2018-07-30
Device Publish Date2015-12-08

On-Brand Devices [XPE Tibial insert, UC]

04711605576673XPE Tibial insert, UC, #7, 17mm
04711605576666XPE Tibial insert, UC, #7, 16mm
04711605576659XPE Tibial insert, UC, #7, 14mm
04711605576642XPE Tibial insert, UC, #7, 12mm
04711605576635XPE Tibial insert, UC, #7, 10mm
04711605576628XPE Tibial insert, UC, #6, 17mm
04711605576611XPE Tibial insert, UC, #6, 16mm
04711605576604XPE Tibial insert, UC, #6, 14mm
04711605576598XPE Tibial insert, UC, #6, 12mm
04711605576581XPE Tibial insert, UC, #6, 10mm
04711605576574XPE Tibial insert, UC, #5, 17mm
04711605576567XPE Tibial insert, UC, #5, 16mm
04711605576550XPE Tibial insert, UC, #5, 14mm
04711605576543XPE Tibial insert, UC, #5, 12mm
04711605576536XPE Tibial insert, UC, #5, 10mm
04711605576529XPE Tibial insert, UC, #4, 17mm
04711605576512XPE Tibial insert, UC, #4, 16mm
04711605576505XPE Tibial insert, UC, #4, 14mm
04711605576499XPE Tibial insert, UC, #4, 12mm
04711605576482XPE Tibial insert, UC, #4, 10mm
04711605576475XPE Tibial insert, UC, #3, 17mm
04711605576468XPE Tibial insert, UC, #3, 16mm
04711605576451XPE Tibial insert, UC, #3, 14mm
04711605576444XPE Tibial insert, UC, #3, 12mm
04711605576437XPE Tibial insert, UC, #3, 10mm
04711605576420XPE Tibial insert, UC, #2, 17mm
04711605576413XPE Tibial insert, UC, #2, 16mm
04711605576406XPE Tibial insert, UC, #2, 14mm
04711605576390XPE Tibial insert, UC, #2, 12mm
04711605576383XPE Tibial insert, UC, #2, 10mm
04711605576376XPE Tibial insert, UC, #1, 17mm
04711605576369XPE Tibial insert, UC, #1, 16mm
04711605576352XPE Tibial insert, UC, #1, 14mm
04711605576345XPE Tibial insert, UC, #1, 12mm
04711605576338XPE Tibial insert, UC, #1, 10mm
04711605567244XPE Tibial insert, UC, #7, 18mm
04711605567237XPE Tibial insert, UC, #7, 15mm
04711605567220XPE Tibial insert, UC, #7, 13mm
04711605567213XPE Tibial insert, UC, #7, 11mm
04711605567206XPE Tibial insert, UC, #7, 9mm
04711605567190XPE Tibial insert, UC, #6, 18mm
04711605567183XPE Tibial insert, UC, #6, 15mm
04711605567176XPE Tibial insert, UC, #6, 13mm
04711605567169XPE Tibial insert, UC, #6, 11mm
04711605567152XPE Tibial insert, UC, #6, 9mm
04711605567145XPE Tibial insert, UC, #5, 18mm
04711605567138XPE Tibial insert, UC, #5, 15mm
04711605567121XPE Tibial insert, UC, #5, 13mm
04711605567114XPE Tibial insert, UC, #5, 11mm
04711605567107XPE Tibial insert, UC, #5, 9mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.