STERIZO TOTAL KNEE SYSTEM M-3201-0002

GUDID B565M320100022

Tibial Tray Size 2

CPM MEDICAL CONSULTANTS, LLC

Cruciate-retaining total knee prosthesis

• Primary Device ID: B565M320100022
• NIH Device Record Key: 87055267-8cce-475a-96ee-b87b703e0f6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIZO TOTAL KNEE SYSTEM
• Version Model Number: REV A
• Catalog Number: M-3201-0002
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565M320100022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142649

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

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