STERIZO Total Knee System M-3111-1203

GUDID B565M311112031

Size 3 Right Femoral Trial CR

CPM MEDICAL CONSULTANTS, LLC

Knee femur prosthesis trial
Primary Device IDB565M311112031
NIH Device Record Key37b55478-0403-4050-8d6f-b7832e908b3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERIZO Total Knee System
Version Model NumberRev A
Catalog NumberM-3111-1203
Company DUNS017138000
Company NameCPM MEDICAL CONSULTANTS, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB565M311112031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


[B565M311112031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-02
Device Publish Date2022-01-25

On-Brand Devices [STERIZO Total Knee System]

B565M330110161Rev A
B565M330110151CR Tibial Insert Size 5 - 9mm
B565M330110141CR Tibial Insert Size 4 - 9mm
B565M330110131CR Tibial Insert Size 3 - 9mm
B565M330110121CR Tibial Insert Size 2 - 9mm
B565M330110111CR Tibial Insert Size 1 - 9mm
B565M320100061Tibial Tray Size 6
B565M320100051Tibial Tray Size 5
B565M320100041Tibial Tray Size 4
B565M320100031Tibial Tray Size 3
B565M320100021Tibial Tray Size 2
B565M320100011Tibial Tray Size 1
B565M310122061Size 6 Right Femoral PS
B565M310122051Size 5 Right Femoral PS
B565M310122041Size 4 Right Femoral PS
B565M310122031Size 3 Right Femoral PS
B565M310122021Size 2 Right Femoral PS
B565M310122011Size 1 Right Femoral PS
B565M310121061STERIZO Total Knee System
B565M310121051Size 5 Left Femoral PS
B565M310121041Size 4 Left Femoral PS
B565M310121031Size 3 Left Femoral PS
B565M310121021Size 2 Left Femoral PS
B565M310121011Size 1 Left Femoral PS
B565M310112061Size 6 Right Femoral CR
B565M310112051Size 5 Right Femoral CR
B565M310112041Size 4 Right Femoral CR
B565M310112031Size 3 Right Femoral CR
B565M310112021Size 2 Right Femoral CR
B565M310112011Size 1 Right Femoral CR
B565M310111061Size 6 Left Femoral CR
B565M310111051Size 5 Left Femoral CR
B565M310111041Size 4 Left Femoral CR
B565M310111031Size 3 Left Femoral CR
B565M310111021Size 2 Left Femoral CR
B565M310111011Size 1 Left Femoral CR
B565M330120141PS Tibial Insert Size 4 9mm
B565M330120131PS Tibial Insert Size 3 9mm
B565M330120121PS Tibial Insert Size 2 9mm
B565M330120111PS Tibial Insert Size 1 9mm
B565M330110561CR Tibial Insert Size 6 - 18mm
B565M330110551CR Tibial Insert Size 5 - 18mm
B565M330110541CR Tibial Insert Size 4 - 18mm
B565M330110531CR Tibial Insert Size 3 - 18mm
B565M330110521CR Tibial Insert Size 2 - 18mm
B565M330110511CR Tibial Insert Size 1 - 18mm
B565M330110461CR Tibial Insert Size 6 - 15mm
B565M330110451CR Tibial Insert Size 5 - 15mm
B565M330110441CR Tibial Insert Size 4 - 15mm
B565M330110431CR Tibial Insert Size 3 - 15mm

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