CentLoc Total Knee System 7131-0814

GUDID 08800036801761

CentLoc Tibial insert component PS type Size6-1 14mm

RootLoc Co., Ltd.

Femur/tibia shaft prosthesis
Primary Device ID08800036801761
NIH Device Record Key1b176ac5-f4f7-476a-b4db-be079e79181e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentLoc Total Knee System
Version Model Number7131-0814
Catalog Number7131-0814
Company DUNS694670830
Company NameRootLoc Co., Ltd.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800036801761 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-30
Device Publish Date2019-09-20

On-Brand Devices [CentLoc Total Knee System]

08800036800337CentLoc Femoral component PS type Right Size9
08800036800320CentLoc Femoral component PS type Right Size9-1
08800036800313CentLoc Femoral component PS type Right Size8
08800036800306CentLoc Femoral component PS type Right Size8-3
08800036800290CentLoc Femoral component PS type Right Size8-2
08800036800283CentLoc Femoral component PS type Right Size8-1
08800036800276CentLoc Femoral component PS type Right Size7
08800036800269CentLoc Femoral component PS type Right Size7-1
08800036800252CentLoc Femoral component PS type Right Size6
08800036800245CentLoc Femoral component PS type Right Size6-1
08800036800238CentLoc Femoral component PS type Right Size6N
08800036800221CentLoc Femoral component PS type Right Size5
08800036800214CentLoc Femoral component PS type Right Size4-1
08800036800207CentLoc Femoral component PS type Right Size4
08800036800191CentLoc Femoral component PS type Right Size3
08800036800184CentLoc Femoral component PS type Right Size2
08800036800177CentLoc Femoral component PS type Right Size1
08800036800160CentLoc Femoral component PS type Left Size9
08800036800153CentLoc Femoral component PS type Left Size9-1
08800036800146CentLoc Femoral component PS type Left Size8
08800036800139CentLoc Femoral component PS type Left Size8-3
08800036800122CentLoc Femoral component PS type Left Size8-2
08800036800115CentLoc Femoral component PS type Left Size8-1
08800036800108CentLoc Femoral component PS type Left Size7
08800036800092CentLoc Femoral component PS type Left Size7-1
08800036800085CentLoc Femoral component PS type Left Size6
08800036800078CentLoc Femoral component PS type Left Size6-1
08800036800061CentLoc Femoral component PS type Left Size6N
08800036800054CentLoc Femoral component PS type Left Size5
08800036800047CentLoc Femoral component PS type Left Size4-1
08800036800030CentLoc Femoral component PS type Left Size4
08800036800023CentLoc Femoral component PS type Left Size3
08800036800016CentLoc Femoral component PS type Left Size 2
08800036800009CentLoc Femoral component PS type Left Size1
08800036800825CentLoc Tibial tray component CCM Size9
08800036800818CentLoc Tibial tray component CCM Size8-4
08800036800801CentLoc Tibial tray component CCM Size8-3
08800036800795CentLoc Tibial tray component CCM Size8-2
08800036800788CentLoc Tibial tray component CCM Size8-1
08800036800771CentLoc Tibial tray component CCM Size8
08800036800764CentLoc Tibial tray component CCM Size7
08800036800757CentLoc Tibial tray component CCM Size6-1
08800036800740CentLoc Tibial tray component CCM Size6
08800036800733CentLoc Tibial tray component CCM Size5
08800036800726CentLoc Tibial tray component CCM Size4-1
08800036800719CentLoc Tibial tray component CCM Size4
08800036800702CentLoc Tibial tray component CCM Size3
08800036800696CentLoc Tibial tray component CCM Size2
08800036800689CentLoc Tibial tray component CCM Size1
08800036800672CentLoc Femoral component CR type Right Size9

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