| Primary Device ID | 10381780366447 |
| NIH Device Record Key | 27296451-e421-4fb5-945e-e1cd0678af83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® XT |
| Version Model Number | LJV193T |
| Catalog Number | LJV193T |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| 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 |
| 10381780374077 | Integra XT, Revision Instrument Case 1 |
| 10381780374060 | Salto Talaris, Caddy Lid |
| 10381780366447 | Talar Dome, Sloped, Size 3, Left |
| 10381780366430 | Talar Dome, Sloped, Size 2, Left |
| 10381780366423 | Talar Dome, Sloped, Size 1, Left |
| 10381780366416 | Talar Dome, Sloped, Size 0, Left |
| 10381780366409 | Talar Dome, Sloped, Size 3, Right |
| 10381780366393 | Talar Dome, Sloped, Size 2, Right |
| 10381780366386 | Talar Dome, Sloped, Size 1, Right |
| 10381780366379 | Talar Dome, Sloped, Size 0, Right |
| 10381780366362 | Tibial Tray, 35mm Fin, TH10, Size 3 |
| 10381780366355 | Tibial Tray, 35mm Fin, TH10, Size 2 |
| 10381780366348 | Tibial Tray, 35mm Fin, TH10, Size 1 |
| 10381780366331 | Tibial Tray, 35mm Fin, TH10, Size 0 |
| 10381780366324 | Tibial Tray, 35mm Fin, TH4, Size 3 |
| 10381780366317 | Tibial Tray, 35mm Fin, TH4, Size 2 |
| 10381780366300 | Tibial Tray, 35mm Fin, TH4, Size 1 |
| 10381780366294 | Tibial Tray, 35mm Fin, TH4, Size 0 |
| 10381780368885 | Assembly spacer for thick tibia |
| 10381780368878 | In situ Poly inserter |
| 10381780368854 | Punching tip |
| 10381780368830 | Tibial holder |
| 10381780368632 | Stabilization Peg |
| 10381780368441 | Joint Distractor, Left |
| 10381780368434 | Joint Distractor, Right |
| 10381780368731 | Tibial trial rasp Size 2, Thick |
| 10381780368724 | Tibial trial rasp Size 1, Thick |
| 10381780368717 | Tibial trial rasp Size 0, Thick |
| 10381780368663 | Insert assembly bench, Long Fin |
| 10381780368748 | Tibial trial rasp Size 3, Thick |
