| Primary Device ID | H98108807325S0 |
| NIH Device Record Key | 3d872af2-6854-4e79-a4ea-539af33e3c6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XRL |
| Version Model Number | 08.807.325S |
| Catalog Number | 08807325S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034755717 [Primary] |
| HIBCC | H98108807325S0 [Secondary] |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2015-09-14 |
| H9810880730002S0 | XRL LARGE ENDPLATE SCREWS- STERILE |
| H9810880720002S0 | XRL MEDIUM ENDPLATE SCREWS- STERILE |
| H98108807345S0 | XRL LARGE ENDPLATE 30MM X 40MM/20 DEG-STERILE |
| H98108807344S0 | XRL LARGE ENDPLATE 30MM X 40MM/15 DEG-STERILE |
| H98108807343S0 | XRL LARGE ENDPLATE 30MM X 40MM/10 DEG-STERILE |
| H98108807342S0 | XRL LARGE ENDPLATE 30MM X 40MM/5 DEG-STERILE |
| H98108807341S0 | XRL LARGE ENDPLATE 30MM X 40MM/0 DEG-STERILE |
| H98108807335S0 | XRL LARGE ENDPLATE 28MM X 33MM/20 DEG-STERILE |
| H98108807334S0 | XRL LARGE ENDPLATE 28MM X 33MM/15 DEG-STERILE |
| H98108807333S0 | XRL LARGE ENDPLATE 28MM X 33MM/10 DEG-STERILE |
| H98108807332S0 | XRL LARGE ENDPLATE 28MM X 33MM/5 DEG-STERILE |
| H98108807331S0 | XRL LARGE ENDPLATE 28MM X 33MM/0 DEG-STERILE |
| H98108807325S0 | XRL LARGE ENDPLATE 27MM ROUND/20 DEG-STERILE |
| H98108807324S0 | XRL LARGE ENDPLATE 27MM ROUND/15 DEG-STERILE |
| H98108807323S0 | XRL LARGE ENDPLATE 27MM ROUND/10 DEG-STERILE |
| H98108807322S0 | XRL LARGE ENDPLATE 27MM ROUND/5 DEG-STERILE |
| H98108807321S0 | XRL LARGE ENDPLATE 27MM ROUND/0 DEG-STERILE |
| H98108807315S0 | XRL LARGE CENTRAL BODY 106MM-121MM HEIGHT-STERILE |
| H98108807314S0 | XRL LARGE CENTRAL BODY 95MM-110MM HEIGHT-STERILE |
| H98108807313S0 | XRL LARGE CENTRAL BODY 84MM-99MM HEIGHT-STERILE |
| H98108807312S0 | XRL LARGE CENTRAL BODY 73MM-88MM HEIGHT-STERILE |
| H98108807311S0 | XRL LARGE CENTRAL BODY 62MM-77MM HEIGHT-STERILE |
| H98108807310S0 | XRL LARGE CENTRAL BODY 51MM-66MM HEIGHT-STERILE |
| H98108807309S0 | XRL LARGE CENTRAL BODY 44MM-59MM HEIGHT-STERILE |
| H98108807308S0 | XRL LARGE CENTRAL BODY 37MM-52MM HEIGHT-STERILE |
| H98108807307S0 | XRL LARGE CENTRAL BODY 33MM-43MM HEIGHT-STERILE |
| H98108807306S0 | XRL LARGE CENTRAL BODY 29MM-39MM HEIGHT-STERILE |
| H98108807305S0 | XRL LARGE CENTRAL BODY 25MM-33MM HEIGHT-STERILE |
| H98108807304S0 | XRL LARGE CENTRAL BODY 22MM-27MM HEIGHT-STERILE |
| H98108807303S0 | XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG-STERILE |
| H98108807302S0 | XRL LARGE IMPLANT-INTEGRATED 25MM-30MM HEIGHT/0 DEG-STERILE |
| H98108807301S0 | XRL LARGE IMPLANT-INTEGRATED 23MM-26MM HEIGHT/0 DEG-STERILE |
| H98108807246S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/15 DEG-STERILE |
| H98108807245S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/10 DEG-STERILE |
| H98108807244S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/5 DEG-STERILE |
| H98108807243S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/0 DEG-STERILE |
| H98108807242S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/-5 DEG-STERILE |
| H98108807241S0 | XRL MEDIUM ENDPLATE 26MM X 30MM/-10 DEG-STERILE |
| H98108807236S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/15 DEG-STERILE |
| H98108807235S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/10 DEG-STERILE |
| H98108807234S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE |
| H98108807233S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/0 DEG-STERILE |
| H98108807232S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/-5 DEG-STERILE |
| H98108807231S0 | XRL MEDIUM ENDPLATE 21MM X 24MM/-10 DEG-STERILE |
| H98108807224S0 | XRL MEDIUM ENDPLATE 21MM ROUND/15 DEG-STERILE |
| H98108807223S0 | XRL MEDIUM ENDPLATE 21MM ROUND/10 DEG-STERILE |
| H98108807222S0 | XRL MEDIUM ENDPLATE 21MM ROUND/5 DEG-STERILE |
| H98108807221S0 | XRL MEDIUM ENDPLATE 21MM ROUND/0 DEG-STERILE |
| H98108807215S0 | XRL MEDIUM CENTRAL BODY 106MM-121MM HEIGHT-STERILE |
| H98108807214S0 | XRL MEDIUM CENTRAL BODY 95MM-110MM HEIGHT-STERILE |