| Primary Device ID | 10889981162702 |
| NIH Device Record Key | f43abe54-74a9-43f6-a99e-b951c2d6279f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regatta Lateral System |
| Version Model Number | 36-99-5000 |
| Catalog Number | 36-99-5000 |
| 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 | 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(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 | 10889981162702 [Primary] |
| OJH | Orthopedic tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
[10889981162702]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-16 |
| Device Publish Date | 2018-09-15 |
| 10889987164793 | Lateral Disc Prep Instrument Tray Case |
| 10889987164786 | Lateral Disc Prep Instrument Tray Level Bottom |
| 10889987164779 | Lateral Disc Prep Instrument Tray Level Top |
| 10889987164762 | Angled Lateral Disc Prep Instrument Tray Case |
| 10889987164755 | Angled Lateral Disc Prep Instrument Tray Bottom |
| 10889987164748 | Angled Lateral Disc Prep Instrument Tray Top |
| 10889987163123 | Lateral Box Cutter, 6x23mm |
| 10889986163117 | Lateral Box Cutter, 4x23mm |
| 10889981170783 | Osteophyte Biter |
| 10889981170776 | Down Biting Curette, Small |
| 10889981163044 | Trial, 23mm x 16mm x 55mm, 15 Deg |
| 10889981163037 | Trial, 23mm x 16mm x 55mm, 10 Deg |
| 10889981163013 | Trial, 23mm x 14mm x 55mm, 15 Deg |
| 10889981163006 | Trial, 23mm x 14mm x 55mm, 10 Deg |
| 10889981162993 | Trial, 23mm x 14mm x 55mm, 0 Deg |
| 10889981162986 | Trial, 23mm x 12mm x 55mm, 15 Deg |
| 10889981162979 | Trial, 23mm x 12mm x 55mm, 10 Deg |
| 10889981162962 | Trial, 23mm x 12mm x 55mm, 0 Deg |
| 10889981162955 | Trial, 23mm x 10mm x 55mm, 15 Deg |
| 10889981162948 | Trial, 23mm x 10mm x 55mm, 10 Deg |
| 10889981162931 | Trial, 23mm x 10mm x 55mm, 0 Deg |
| 10889981162924 | Trial, 23mm x 8mm x 55mm, 10 Deg |
| 10889981162917 | Trial, 23mm x 8mm x 55mm, 0 Deg |
| 10889981162900 | Trial, 18mm x 16mm x 55mm, 15 Deg |
| 10889981162894 | Trial, 18mm x 16mm x 55mm, 10 Deg |
| 10889981162870 | Trial, 18mm x 14mm x 55mm, 15 Deg |
| 10889981162863 | Trial, 18mm x 14mm x 55mm, 10 Deg |
| 10889981162856 | Trial, 18mm x 14mm x 55mm, 0 Deg |
| 10889981162849 | Trial, 18mm x 12mm x 55mm, 15 Deg |
| 10889981162832 | Trial, 18mm x 12mm x 55mm, 10 Deg |
| 10889981162825 | Trial, 18mm x 12mm x 55mm, 0 Deg |
| 10889981162818 | Trial, 18mm x 10mm x 55mm, 15 Deg |
| 10889981162801 | Trial, 18mm x 10mm x 55mm, 10 Deg |
| 10889981162795 | Trial, 18mm x 10mm x 55mm, 0 Deg |
| 10889981162788 | Trial, 18mm x 8mm x 55mm, 10 Deg |
| 10889981162771 | Trial, 18mm x 8mm x 55mm, 0 Deg |
| 10889981162764 | Regatta Instrument Tray Non-Lordotic Trial Caddy |
| 10889981162757 | Regatta Instrument Tray Wide Trial Caddy |
| 10889981162740 | Regatta Instrument Tray Narrow Trial Caddy |
| 10889981162733 | Regatta Instrument Tray Case |
| 10889981162726 | Regatta Instrument Tray Level Bottom |
| 10889981162719 | Regatta Instrument Tray Level Top |
| 10889981162702 | Regatta Instrument Tray |
| 10889981162665 | Lateral Paddle Shaver, 6mm |
| 10889981162658 | Lateral Paddle Shaver, 4mm |
| 10889981162641 | Lateral Box Cutter, 6x23mm, Angled |
| 10889981162634 | Lateral Box Cutter, 4x23mm, Angled |
| 10889981162627 | Lateral Box Cutter, 4x18mm, Angled |
| 10889981162610 | Lateral Box Cutter, 6x18mm |
| 10889981162603 | Lateral Box Cutter, 4x18mm, Angled |