SIGMA RPF AOX 196191011

GUDID 10603295075738

SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 12.5mm

DEPUY ORTHOPAEDICS, INC.

Tibial insert
Primary Device ID10603295075738
NIH Device Record Key58648708-d111-49d8-8969-59911525d881
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIGMA RPF AOX
Version Model Number1961-91-011
Catalog Number196191011
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
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+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295075738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-04
Device Publish Date2015-03-24

On-Brand Devices [SIGMA RPF AOX]

10603295076032SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 17.5mm
10603295076025SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 15mm
10603295076018SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 12.5mm
10603295076001SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 10mm
10603295075998SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 17.5mm
10603295075981SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 15mm
10603295075974SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 12.5mm
10603295075967SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 10mm
10603295075950SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 17.5mm
10603295075943SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 15mm
10603295075936SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 12.5mm
10603295075929SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 10mm
10603295075912SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 17.5mm
10603295075905SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 15mm
10603295075899SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 12.5mm
10603295075882SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 10mm
10603295075875SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 17.5mm
10603295075868SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 15mm
10603295075851SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 12.5mm
10603295075844SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 10mm
10603295075837SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 17.5mm
10603295075820SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 15mm
10603295075813SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 12.5mm
10603295075806SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 10mm
10603295075790SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 17.5mm
10603295075783SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 15mm
10603295075776SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 12.5mm
10603295075769SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 10mm
10603295075752SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 17.5mm
10603295075745SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 15mm
10603295075738SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 12.5mm
10603295075721SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 10mm

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