| Primary Device ID | H981038076430 |
| NIH Device Record Key | f65624b2-c8f6-4bea-b5be-d38f86394707 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XRL |
| Version Model Number | 03.807.643 |
| Catalog Number | 03807643 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | +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 | 07611819407275 [Direct Marking] |
| GS1 | 10705034724027 [Primary] |
| HIBCC | H981038076430 [Secondary] |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981038076430]
Moist Heat or Steam Sterilization
[H981038076430]
Moist Heat or Steam Sterilization
[H981038076430]
Moist Heat or Steam Sterilization
[H981038076430]
Moist Heat or Steam Sterilization
[H981038076430]
Moist Heat or Steam Sterilization
[H981038076430]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-06-01 |
| Device Publish Date | 2015-09-14 |
| 07611819406971 | XRL LARGE GRAFT PACKING PREPARATION TAMP |
| 07611819406377 | XRL MEDIUM GRAFT PACKING PREPARATION TAMP |
| 07611819406964 | XRL LARGE GRAFT PACKING TAMP |
| 07611819406360 | XRL MEDIUM GRAFT PACKING TAMP |
| 07611819419087 | XRL LARGE TORQUE LIMITING HANDLE |
| 07611819419070 | XRL MEDIUM TORQUE LIMITING HANDLE |
| H981038073560 | XRL LARGE SPREADER TOP WITH 5MM DISTRACTION (INTEGRATED) |
| H981038073550 | XRL MEDIUM SPREADER TOP WITH 5MM DISTRACTION (INTEGRATED) |
| 07611819406322 | XRL ENDPLATE REMOVAL TOOL |
| H981038073000 | XRL SPREADER |
| H981038076450 | XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/20 DEG |
| H981038076440 | XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/15 DEG |
| H981038076430 | XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/10 DEG |
| H981038076420 | XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/5 DEG |
| H981038076410 | XRL LARGE TRIAL-ENDPLATE 30MM X 40MM/0 DEG |
| H981038076350 | XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/20 DEG |
| H981038076340 | XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/15 DEG |
| H981038076330 | XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/10 DEG |
| H981038076320 | XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/5 DEG |
| H981038076310 | XRL LARGE TRIAL-ENDPLATE 28MM X 33MM/0 DEG |
| H981038076250 | XRL LARGE TRIAL-ENDPLATE 27MM ROUND/20 DEG |
| H981038076240 | XRL LARGE TRIAL-ENDPLATE 27MM ROUND/15 DEG |
| H981038076230 | XRL LARGE TRIAL-ENDPLATE 27MM ROUND/10 DEG |
| H981038076220 | XRL LARGE TRIAL-ENDPLATE 27MM ROUND/5 DEG |
| H981038076210 | XRL LARGE TRIAL-ENDPLATE 27MM ROUND/0 DEG |
| H981038076150 | XRL LARGE TRIAL-CENTRAL BODY 106MM-121MM HEIGHT |
| H981038076140 | XRL LARGE TRIAL-CENTRAL BODY 95MM-110MM HEIGHT |
| H981038076130 | XRL LARGE TRIAL-CENTRAL BODY 84MM-99MM HEIGHT |
| H981038076120 | XRL LARGE TRIAL-CENTRAL BODY 73MM-88MM HEIGHT |
| H981038076110 | XRL LARGE TRIAL-CENTRAL BODY 62MM-77MM HEIGHT |
| H981038076100 | XRL LARGE TRIAL-CENTRAL BODY 51MM-66MM HEIGHT |
| H981038076090 | XRL LARGE TRIAL-CENTRAL BODY 44MM-59MM HEIGHT |
| H981038076080 | XRL LARGE TRIAL-CENTRAL BODY 37MM-52MM HEIGHT |
| H981038076070 | XRL LARGE TRIAL-CENTRAL BODY 33MM-43MM HEIGHT |
| H981038076060 | XRL LARGE TRIAL-CENTRAL BODY 29MM-39MM HEIGHT |
| H981038076050 | XRL LARGE TRIAL-CENTRAL BODY 25MM-33MM HEIGHT |
| H981038076040 | XRL LARGE TRIAL-CENTRAL BODY 22MM-27MM HEIGHT |
| H981038076030 | XRL LARGE TRIAL-INTEGRATED 29MM-37MM HEIGHT/0 DEG |
| H981038076020 | XRL LARGE TRIAL-INTEGRATED 25MM-30MM HEIGHT/0 DEG |
| H981038076010 | XRL LARGE TRIAL-INTEGRATED 23MM-26MM HEIGHT/0 DEG |
| H981038075460 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/15 DEG |
| H981038075450 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/10 DEG |
| H981038075440 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/5 DEG |
| H981038075430 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/0 DEG |
| H981038075420 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/-5 DEG |
| H981038075410 | XRL MEDIUM TRIAL-ENDPLATE 26MM X 30MM/-10 DEG |
| H981038075360 | XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/15 DEG |
| H981038075350 | XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/10 DEG |
| H981038075340 | XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/5 DEG |
| H981038075330 | XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/0 DEG |