| Primary Device ID | 10889981062255 |
| NIH Device Record Key | 5c847c2b-b801-4b4a-b376-f44d6068c4fe |
| Commercial Distribution Discontinuation | 2018-01-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Integra Expandable Interbody |
| Version Model Number | EXPIMP |
| Catalog Number | EXPIMP |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com | |
| Phone | +1(866)942-8698 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981062255 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
[10889981062255]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-08 |
| Device Publish Date | 2015-09-24 |
| 10889981062255 | Expandable IBD Implants |
| 10889981049645 | 30mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic |
| 10889981049638 | 26mm Implant Caddyy. The Integra Expandable IBD System consists of lumbar interbody fusion devic |
| 10889981049621 | 22mm Implant Caddy. The Integra Expandable IBD System consists of lumbar interbody fusion device |
| 10889981049614 | Implant Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu |
| 10889981049607 | Instrument Tray. The Integra Expandable IBD System consists of lumbar interbody fusion devices m |
| 10889981049591 | Guide Hex Rod. The Integra Expandable IBD System consists of lumbar interbody fusion devices man |
| 10889981049584 | Bone Funnel. The Integra Expandable IBD System consists of lumbar interbody fusion devices manuf |
| 10889981049577 | Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactur |
| 10889981049560 | 18mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049553 | 17mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049546 | 16mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049539 | 15mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049522 | 14mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049515 | 13mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049508 | 12mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049492 | 11mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049485 | 10mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusi |
| 10889981049478 | 9mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio |
| 10889981049461 | 8mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusio |
| 10889981049454 | 6mm Starter Trial. The Integra Expandable IBD System consists of lumbar interbody fusion devices |
| 10889981049447 | 12mm Wide Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion de |
| 10889981049430 | Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manu |
| 10889981049423 | Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices |
| 10889981049416 | Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices |
| 10889981049409 | Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact |
| 10889981049393 | Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufact |
| 10889981049386 | IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049379 | IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049362 | IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |
| 10889981049355 | IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049348 | IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049331 | IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |
| 10889981049324 | IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049317 | IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049300 | IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |
| 10889981049294 | IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049287 | IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049270 | IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |
| 10889981049263 | IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049256 | IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049249 | IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |
| 10889981049232 | IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049225 | IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumb |
| 10889981049218 | IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG. The Integra Expandable IBD System consists of lumba |