| Primary Device ID | B565M331140511 |
| NIH Device Record Key | fbf4efe5-9f46-4c9d-a356-e66088b44d6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERIZO Total Knee System |
| Version Model Number | Rev A |
| Catalog Number | M-3311-4051 |
| 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 |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B565M331140511 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
[B565M331140511]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-02 |
| Device Publish Date | 2022-01-25 |
| 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 |