STERIZO Total Knee System M-3111-1101

GUDID B565M311111011

Size 1 Left Femoral Trial CR

CPM MEDICAL CONSULTANTS, LLC

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Primary Device ID	B565M311111011
NIH Device Record Key	900e07b8-6dc8-4921-afb2-277baad19230
Commercial Distribution Status	In Commercial Distribution
Brand Name	STERIZO Total Knee System
Version Model Number	Rev A
Catalog Number	M-3111-1101
Company DUNS	017138000
Company Name	CPM MEDICAL CONSULTANTS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565M311111011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150783

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

[B565M311111011]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-02
Device Publish Date	2022-01-25

On-Brand Devices [STERIZO Total Knee System]

B565M330110161	Rev A
B565M330110151	CR Tibial Insert Size 5 - 9mm
B565M330110141	CR Tibial Insert Size 4 - 9mm
B565M330110131	CR Tibial Insert Size 3 - 9mm
B565M330110121	CR Tibial Insert Size 2 - 9mm
B565M330110111	CR Tibial Insert Size 1 - 9mm
B565M320100061	Tibial Tray Size 6
B565M320100051	Tibial Tray Size 5
B565M320100041	Tibial Tray Size 4
B565M320100031	Tibial Tray Size 3
B565M320100021	Tibial Tray Size 2
B565M320100011	Tibial Tray Size 1
B565M310122061	Size 6 Right Femoral PS
B565M310122051	Size 5 Right Femoral PS
B565M310122041	Size 4 Right Femoral PS
B565M310122031	Size 3 Right Femoral PS
B565M310122021	Size 2 Right Femoral PS
B565M310122011	Size 1 Right Femoral PS
B565M310121061	STERIZO Total Knee System
B565M310121051	Size 5 Left Femoral PS
B565M310121041	Size 4 Left Femoral PS
B565M310121031	Size 3 Left Femoral PS
B565M310121021	Size 2 Left Femoral PS
B565M310121011	Size 1 Left Femoral PS
B565M310112061	Size 6 Right Femoral CR
B565M310112051	Size 5 Right Femoral CR
B565M310112041	Size 4 Right Femoral CR
B565M310112031	Size 3 Right Femoral CR
B565M310112021	Size 2 Right Femoral CR
B565M310112011	Size 1 Right Femoral CR
B565M310111061	Size 6 Left Femoral CR
B565M310111051	Size 5 Left Femoral CR
B565M310111041	Size 4 Left Femoral CR
B565M310111031	Size 3 Left Femoral CR
B565M310111021	Size 2 Left Femoral CR
B565M310111011	Size 1 Left Femoral CR
B565M330120141	PS Tibial Insert Size 4 9mm
B565M330120131	PS Tibial Insert Size 3 9mm
B565M330120121	PS Tibial Insert Size 2 9mm
B565M330120111	PS Tibial Insert Size 1 9mm
B565M330110561	CR Tibial Insert Size 6 - 18mm
B565M330110551	CR Tibial Insert Size 5 - 18mm
B565M330110541	CR Tibial Insert Size 4 - 18mm
B565M330110531	CR Tibial Insert Size 3 - 18mm
B565M330110521	CR Tibial Insert Size 2 - 18mm
B565M330110511	CR Tibial Insert Size 1 - 18mm
B565M330110461	CR Tibial Insert Size 6 - 15mm
B565M330110451	CR Tibial Insert Size 5 - 15mm
B565M330110441	CR Tibial Insert Size 4 - 15mm
B565M330110431	CR Tibial Insert Size 3 - 15mm

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