| Primary Device ID | 10889981206598 |
| NIH Device Record Key | 925efd10-f16b-42f8-9167-9da3eb4d3ca5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Explorer TO |
| Version Model Number | ET1-303211 |
| Catalog Number | ET1-303211 |
| Company DUNS | 079840876 |
| Company Name | SEASPINE ORTHOPEDICS CORPORATION |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981206598 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981206598]
Moist Heat or Steam Sterilization
[10889981206598]
Moist Heat or Steam Sterilization
[10889981206598]
Moist Heat or Steam Sterilization
[10889981206598]
Moist Heat or Steam Sterilization
[10889981206598]
Moist Heat or Steam Sterilization
[10889981206598]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-01 |
| Device Publish Date | 2022-05-24 |
| 10889981220723 | Caddy - Height Expansion, 9mm Width |
| 10889981220716 | Caddy - Lordosis Expansion, 9mm Width |
| 10889981220709 | Tray - Bottom Level |
| 10889981220693 | Tray - Top Level |
| 10889981220686 | Tray - Base |
| 10889981210854 | 12mm Trial, 9mm Wide, Centered |
| 10889981210847 | 10mm Trial, 9mm Wide, Centered |
| 10889981210830 | 8mm Trial, 9mm Wide, Centered |
| 10889981210809 | Torque Limiting Handle, 22.5in-lb |
| 10889981207335 | Syringe Adapter |
| 10889981207328 | Bone Cartridge Pusher |
| 10889981207304 | Bone Cartridge Base |
| 10889981207298 | Bone Delivery Rack Plunger |
| 10889981207281 | Bone Delivery Tower |
| 10889981207274 | Bone Cartridge |
| 10889981207267 | Auger |
| 10889981207250 | Slap Hammer |
| 10889981207243 | 12mm Trial, 9mm Wide |
| 10889981207236 | 10mm Trial, 9mm Wide |
| 10889981207229 | 8mm Trial, 9mm Wide |
| 10889981207212 | 6mm Trial, 9mm Wide |
| 10889981207199 | Height Expansion Driver |
| 10889981207182 | Lordosis Expansion Driver |
| 10889981207168 | Inserter Wrench |
| 10889981207151 | Impaction Cap |
| 10889981207144 | Inserter Handle |
| 10889981207137 | Inserter |
| 10889981206772 | Height Expansion, 9mm x 32mm x 12-16mm, 8 Deg |
| 10889981206758 | Height Expansion, 9mm x 32mm x 10-14mm, 8 Deg |
| 10889981206741 | Height Expansion, 9mm x 28mm x 12-16mm, 8 Deg |
| 10889981206727 | Height Expansion, 9mm x 28mm x 10-14mm, 8 Deg |
| 10889981206604 | Height Expansion, 9mm x 32mm x 12-16mm, 0 Deg |
| 10889981206581 | Height Expansion, 9mm x 32mm x 10-14mm, 0 Deg |
| 10889981206567 | Height Expansion, 9mm x 32mm x 8-12mm, 0 Deg |
| 10889981206550 | Height Expansion, 9mm x 32mm x 7-11mm, 0 Deg |
| 10889981206543 | Height Expansion, 9mm x 28mm x 12-16mm, 0 Deg |
| 10889981206529 | Height Expansion, 9mm x 28mm x 10-14mm, 0 Deg |
| 10889981206505 | Height Expansion, 9mm x 28mm x 8-12mm, 0 Deg |
| 10889981206499 | Height Expansion, 9mm x 28mm x 7-11mm, 0 Deg |
| 10889981206482 | Lordosis Expansion, 9x30x10mm, 3-17 Deg |
| 10889981206475 | Lordosis Expansion, 9x26x10mm, 3-17 Deg |
| 10889981206468 | Lordosis Expansion, 9x26x12mm, 6-20 Deg |
| 10889981184919 | Lordosis Expansion, 9x30x8mm, 0-14 Deg |
| 10889981184902 | Lordosis Expansion, 9x26x8mm, 0-14 Deg |
| 10889981184896 | Lordosis Expansion, 9x30x12mm, 6-20 Deg |
| 10889981292348 | Bone Delivery Rack Plunger |
| 10889981289560 | Caddy - Height Expansion, 9mm Width |
| 10889981289553 | Caddy - Lordosis Expansion, 9mm Width |
| 10889981289546 | Inserter Wrench |
| 10889981289300 | Tray - Bottom Level |