| Primary Device ID | B565M32124540R1 |
| NIH Device Record Key | 321865ba-8c54-4fa5-b0e3-4db51dc66df2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tibial Revision Platform |
| Version Model Number | Rev A |
| 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 | B565M32124540R1 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
[B565M32124540R1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-15 |
| Device Publish Date | 2022-02-07 |
| B565M32024615R0 | Tibial Augment Size 6, 15mm Right |
| B565M32024615L0 | Tibial Augment Size 6, 15mm Left |
| B565M32024610R0 | Tibial Augment Size 6, 10mm Right |
| B565M32024610L0 | Tibial Augment Size 6, 10mm Left |
| B565M32024605N0 | Tibial Augment Size 6, 5mm Neutral |
| B565M32024515R0 | Tibial Augment Size 5, 15mm Right |
| B565M32024515L0 | Tibial Augment Size 5, 15mm Left |
| B565M32024510R0 | Tibial Augment Size 5, 10mm Right |
| B565M32024510L0 | Tibial Augment Size 5, 10mm Left |
| B565M32024505N0 | Tibial Augment Size 5, 5mm Neutral |
| B565M32024415R0 | Tibial Augment Size 4, 15mm Right |
| B565M32024415L0 | Tibial Augment Size 4, 15mm Left |
| B565M32024410R0 | Tibial Augment Size 4, 10mm Right |
| B565M32024410L0 | Tibial Augment Size 4, 10mm Left |
| B565M32024405N0 | Tibial Augment Size 4, 5mm Neutral |
| B565M32024315R0 | Tibial Augment Size 3, 15mm Right |
| B565M32024315L0 | Tibial Augment Size 3, 15mm Left |
| B565M32024310R0 | Tibial Augment Size 3, 10mm Right |
| B565M32024310L0 | Tibial Augment Size 3, 10mm Left |
| B565M32024305N0 | Tibial Augment Size 3, 5mm Neutral |
| B565M32024215R0 | Tibial Augment Size 2, 15mm Right |
| B565M32024215L0 | Tibial Augment Size 2, 15mm Left |
| B565M32024210R0 | Tibial Augment Size 2, 10mm Right |
| B565M32024210L0 | Tibial Augment Size 2, 10mm Left |
| B565M32024205N0 | Tibial Augment Size 2, 5mm Neutral |
| B565M32024115R0 | Tibial Augment Size 1, 15mm Right |
| B565M32024115L0 | Tibial Augment Size 1, 15mm Left |
| B565M32024110R0 | Tibial Augment Size 1, 10mm Right |
| B565M32024110L0 | Tibial Augment Size 1, 10mm Left |
| B565M32024105N0 | Tibial Augment Size 1, 5mm Neutral |
| B565M32024015R0 | Tibial Augment Size 0, 15mm Right |
| B565M32024015L0 | Tibial Augment Size 0, 15mm Left |
| B565M32024010R0 | Tibial Augment Size 0, 10mm Right |
| B565M32024010L0 | Tibial Augment Size 0, 10mm Left |
| B565M32024005N0 | Tibial Augment Size 0, 5mm Neutral |
| B565M320230060 | Stem Offset Adapter 6mm |
| B565M320230040 | Stem Offset Adapter 4mm |
| B565M320230020 | Stem Offset Adapter 2mm |
| B565M320220750 | Stem 20mm x 75mm - Press-Fit |
| B565M320220150 | Stem 20mm x 150mm - Press-Fit |
| B565M320220100 | Stem 20mm x 100mm - Press-Fit |
| B565M320218750 | Stem 18mm x 75mm - Press-Fit |
| B565M320218150 | Stem 18mm x 150mm - Press-Fit |
| B565M320218100 | Stem 18mm x 100mm - Press-Fit |
| B565M320216750 | Stem 16mm x 75mm - Press-Fit |
| B565M320216150 | Stem 16mm x 150mm - Press-Fit |
| B565M320216100 | Stem 16mm x 100mm - Press-Fit |
| B565M320214750 | Stem 14mm x 75mm - Press-Fit |
| B565M320214300 | Stem 14mm x 30mm - Cemented |
| B565M320214150 | Stem 14mm x 150mm - Press-Fit |