| Primary Device ID | 10889981123420 |
| NIH Device Record Key | 42b38890-e6f5-4ec6-9267-d74eb5edb55c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeaSpine 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(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com | |
| Phone | +1(760)727-8399 |
| custsvcspine@seaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981123420 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
Moist Heat or Steam Sterilization
[10889981123420]
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 | 2017-05-12 |
| 10889981123864 | 30mm Implant Caddy |
| 10889981123857 | 26mm Implant Caddy |
| 10889981123840 | 22mm Implant Caddy |
| 10889981123833 | Implant Tray |
| 10889981123826 | Instrument Tray |
| 10889981123819 | Guide Hex Rod |
| 10889981123802 | Bone Funnel |
| 10889981123796 | Driver |
| 10889981123789 | 18mm Trial (22x10mm, 0 deg) |
| 10889981123772 | 17mm Trial (22x10mm, 0 deg) |
| 10889981123765 | 16mm Trial (22x10mm, 0 deg) |
| 10889981123758 | 15mm Trial (22x10mm, 0 deg) |
| 10889981123741 | 14mm Trial (22x10mm, 0 deg) |
| 10889981123734 | 13mm Trial (22x10mm, 0 deg) |
| 10889981123727 | 12mm Trial (22x10mm, 0 deg) |
| 10889981123710 | 11mm Trial (22x10mm, 0 deg) |
| 10889981123703 | 10mm Trial (22x10mm, 0 deg) |
| 10889981123697 | 9mm Trial (22x10mm, 0 deg) |
| 10889981123680 | 8mm Trial (22x10mm, 0 deg) |
| 10889981123673 | 6mm Starter Trial |
| 10889981123666 | 12mm Wide Removal Tool |
| 10889981123659 | Removal Tool |
| 10889981123642 | Expansion Driver |
| 10889981123635 | Expansion Driver |
| 10889981123628 | Inserter |
| 10889981123611 | Inserter |
| 10889981123604 | IMPLANT, 30mm LG, 12-18mm HT, 12mm WD, 0 DEG |
| 10889981123598 | IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG |
| 10889981123581 | IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG |
| 10889981123574 | IMPLANT, 30mm LG, 12-18mm HT, 10mm WD, 0 DEG |
| 10889981123567 | IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG |
| 10889981123550 | IMPLANT, 30mm LG, 8-12mm HT, 10mm WD, 0 DEG |
| 10889981123543 | IMPLANT, 26mm LG, 12-18mm HT, 12mm WD, 0 DEG |
| 10889981123536 | IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG |
| 10889981123529 | IMPLANT, 26mm LG, 8-12mm HT, 12mm WD, 0 DEG |
| 10889981123512 | IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG |
| 10889981123505 | IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG |
| 10889981123499 | IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG |
| 10889981123482 | IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG |
| 10889981123475 | IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG |
| 10889981123468 | IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG |
| 10889981123451 | IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG |
| 10889981123444 | IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG |
| 10889981123437 | IMPLANT, 22mm LG, 8-12mm HT, 10mm WD, 0 DEG |
| 10889981123420 | Expandable IBD Implants |
| 10889981120764 | Inserter |