| Primary Device ID | B565M32124510R1 |
| NIH Device Record Key | f002312a-349f-4095-ae07-4028314e0296 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIBIAL REVISON PLATFORM |
| Version Model Number | REV C |
| Catalog Number | M-3212-4510-R |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B565M32124510R1 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
[B565M32124510R1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-04 |
| Device Publish Date | 2022-03-25 |
| B565M32124605R1 | TIBIAL AUGMENT TRIAL SZ 6 5MM RIGHT |
| B565M32124605L1 | TIBIAL AUGMENT TRIAL SZ 6 5MM LEFT |
| B565M32124510R1 | TIBIAL AUGMENT TRIAL SZ 5 10MM RIGHT |
| B565M32124505R1 | TIBIAL AUGMENT TRIAL SZ 5 5MM RIGHT |
| B565M32124505L1 | TIBIAL AUGMENT TRIAL SZ 5 5MM LEFT |
| B565M32124405R1 | TIBIAL AUGMENT TRIAL SZ 4 5MM RIGHT |
| B565M32124405L1 | TIBIAL AUGMENT TRIAL SZ 4 5MM LEFT |
| B565M32124305R1 | TIBIAL AUGMENT TRIAL SZ 3 5MM RIGHT |
| B565M32124305L1 | TIBIAL AUGMENT TRIAL SZ 3 5MM LEFT |
| B565M32124205R1 | TIBIAL AUGMENT TRIAL SZ 2 5MM RIGHT |
| B565M32124205L1 | TIBIAL AUGMENT TRIAL SZ 2 5MM LEFT |
| B565M32124105R1 | TIBIAL AUGMENT TRIAL SZ 1 5MM RIGHT |
| B565M32124105L1 | TIBIAL AUGMENT TRIAL SZ 1 5MM LEFT |
| B565M32124005R1 | TIBIAL AUGMENT TRIAL SZ 0 5MM RIGHT |
| B565M32124005L1 | TIBIAL AUGMENT TRIAL SZ 0 5MM LEFT |