| Primary Device ID | 10889981153083 |
| NIH Device Record Key | 12a16590-9df7-49bd-9034-b2f4ea827a2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Daytona Small Stature |
| Version Model Number | 97-6328 |
| Catalog Number | 97-6328 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981153083 [Primary] |
| HWX | TAP, BONE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
[10889981153083]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2018-06-23 |
| 10889985163101 | Sm Stat Hooks, Conn Tray, Axial Conn Caddy |
| 10889985163095 | Axial Hook Inserter Sleeve |
| 10889981161293 | Connector Set Screw, Replacement |
| 10889981156770 | Laminar Hook, 12.0 x 8.0mm |
| 10889981156763 | Laminar Hook, 12.0 x 6.5mm |
| 10889981156756 | Laminar Hook, 12.0 x 12.0mm |
| 10889981156749 | Laminar Hook, 12.0 x 10.0mm |
| 10889981156732 | Laminar Hook, 10.0 x 8.0mm |
| 10889981156725 | Laminar Hook, 10.0 x 6.5mm |
| 10889981156718 | Laminar Hook, 10.0 x 5.5mm |
| 10889981156701 | Laminar Hook, 10.0 x 10.0mm |
| 10889981155346 | Laminar Hook, 5.25 x 8.0mm |
| 10889981155339 | Laminar Hook, 5.25 x 6.5mm |
| 10889981155322 | Laminar Hook, 5.25 x 5.5mm |
| 10889981155315 | Laminar Hook, 5.25 x 4.25mm |
| 10889981155308 | Laminar Hook, 8.0 x 8.0mm |
| 10889981155292 | Laminar Hook, 8.0 x 6.5mm |
| 10889981155285 | Laminar Hook, 8.0 x 5.5mm |
| 10889981155278 | Laminar Hook, 8.0 x 4.25mm |
| 10889981155261 | Offset Hook, 4.0 x 8.0mm, Right |
| 10889981155254 | Offset Hook, 4.0 x 8.0mm, Left |
| 10889981155247 | Angled Hook, 4.0 x 8.0mm, Right |
| 10889981155230 | Angled Hook, 4.0 x 8.0mm, Left |
| 10889981153199 | Sm Stat Hooks, Conn Tray, CrossBar Caddy |
| 10889981153182 | Sm Stat Hooks, Conn Tray, Ext Axial Conn Caddy |
| 10889981153168 | Sm Stat Hooks, Conn Tray, Level 2 |
| 10889981153151 | Sm Stat Hooks, Conn Tray, Add Hook Caddy |
| 10889981153144 | Sm Stat Hooks, Conn Tray, Asst Hook Caddy |
| 10889981153137 | Sm Stat Hooks, Conn Tray, Lam Hook Caddy |
| 10889981153120 | Sm Stat Hooks, Conn Tray, Level 1 |
| 10889981153113 | Sm Stat Hooks, Conn Tray, Base |
| 10889981153106 | 4mm Driver, Tri-Flat, Small Stature |
| 10889981153090 | Tap 8.0mm, Tri-Flat, Cannulated (for 8.5mm Screw) |
| 10889981153083 | Tap 7.5mm, Tri-Flat, Cannulated (for 8.0mm Screw) |
| 10889981153076 | Tap 7.0mm, Tri-Flat, Cannulated (for 7.5mm Screw) |
| 10889981153069 | Tap 6.5mm, Tri-Flat, Cannulated (for 7.0mm Screw) |
| 10889981153052 | Tap 6.0mm, Tri-Flat, Cannulated (for 6.5mm Screw) |
| 10889981153045 | Tap 5.5mm, Tri-Flat, Cannulated (for 6.0mm Screw) |
| 10889981153038 | Tap 5.0mm, Tri-Flat, Cannulated (for 5.5mm Screw) |
| 10889981153021 | Tap 4.5mm, Tri-Flat, Cannulated (for 5.0mm Screw) |
| 10889981153014 | Tap 4.0mm, Tri-Flat, Cannulated (for 4.5mm Screw) |
| 10889981153007 | Locking Driver Shaft, Tri-Flat, Small Stature |
| 10889981152987 | Fixed CrossBar Sizing Tool, Small Stature |
| 10889981152970 | Fixed CrossBar Contouring Handle, Right, Sm Stat |
| 10889981152963 | Fixed CrossBar Contouring Handle, Left, Sm Stat |
| 10889981152956 | Fixed CrossBar Inserter, Small Stature |
| 10889981152949 | Axial Hook Inserter, Shaft, Small Stature |
| 10889981152932 | Pedicle Finder, Small Stature |
| 10889981152925 | Lamina/Transverse Process Finder, Small Stature |
| 10889981152918 | Hook Pusher, Small Stature |