| Primary Device ID | 03701089523837 |
| NIH Device Record Key | bb18ec5b-e989-40c0-add8-f226f2d2b499 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crescendo Tibial Component Cemented - Size 6 |
| Version Model Number | 1-01-07-4006 |
| Company DUNS | 634855407 |
| Company Name | AMPLITUDE SAS |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701089523837 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-10-16 |
| 03701089501071 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514309 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514316 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514323 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514330 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514347 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514354 - VENTO Fixation Screw | 2024-02-19 |
| 03701089514361 - VENTO Fixation Screw | 2024-02-19 |