Daytona® Small Stature 79-0004
GUDID 10889981185664
CoCr Locking Cap 4.5mm, Small Stature, T25
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981185664 |
| NIH Device Record Key | 5fd38128-741e-482c-9c77-a3bb876cf069 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Daytona® Small Stature |
| Version Model Number | 79-0004 |
| Catalog Number | 79-0004 |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981185664 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200381
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
[10889981185664]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-20 |
| Device Publish Date | 2020-08-12 |
On-Brand Devices [Daytona® Small Stature]
| 10889981217396 | Sm Stat Hooks, Conn Tray, Axial Conn Caddy |
| 10889981230715 | Cann Uni-Planar Screw, 7.5 x 70mm, Sm Stat |
| 10889981230708 | Cann Uni-Planar Screw, 7.5 x 65mm, Sm Stat |
| 10889981230692 | Cann Uni-Planar Screw, 6.5 x 70mm, Sm Stat |
| 10889981230685 | Cann Uni-Planar Screw, 6.5 x 65mm, Sm Stat |
| 10889981212315 | Box Wrench |
| 10889981212308 | Derotation Sleeve, Short, Small Stature |
| 10889981212292 | Derotation Tube, Short, Small Stature |
| 10889981212285 | Derotation Sleeve, Long, Small Stature |
| 10889981212278 | Derotation Tube, Long, Small Stature |
| 10889981212254 | Extended Axial Connector, Screw, 3mm OZAT |
| 10889981212063 | Small Stature Uni Tray, Level 1 |
| 10889981212056 | Small Stature Uni Tray, Screw Caddy |
| 10889981212049 | Small Stature Uni Tray, Base |
| 10889981187620 | Solid Polyaxial Screw, 7.5 x 95mm, Sm Stat |
| 10889981187613 | Solid Polyaxial Screw, 7.5 x 90mm, Sm Stat |
| 10889981187606 | Solid Polyaxial Screw, 7.5 x 85mm, Sm Stat |
| 10889981187590 | Solid Polyaxial Screw, 7.5 x 80mm, Sm Stat |
| 10889981187583 | Solid Polyaxial Screw, 7.5 x 75mm, Sm Stat |
| 10889981187576 | Solid Polyaxial Screw, 7.5 x 60mm, Sm Stat |
| 10889981187569 | Solid Polyaxial Screw, 7.5 x 55mm, Sm Stat |
| 10889981187552 | Solid Polyaxial Screw, 7.5 x 50mm, Sm Stat |
| 10889981187545 | Solid Polyaxial Screw, 7.5 x 45mm, Sm Stat |
| 10889981187538 | Solid Polyaxial Screw, 7.5 x 40mm, Sm Stat |
| 10889981187521 | Solid Polyaxial Screw, 7.5 x 35mm, Sm Stat |
| 10889981187514 | Solid Polyaxial Screw, 7.5 x 30mm, Sm Stat |
| 10889981187491 | Solid Polyaxial Screw, 7.5 x 110mm, Sm Stat |
| 10889981187484 | Solid Polyaxial Screw, 7.5 x 105mm, Sm Stat |
| 10889981187477 | Solid Polyaxial Screw, 7.5 x 100mm, Sm Stat |
| 10889981187460 | Solid Polyaxial Screw, 6.5 x 95mm, Sm Stat |
| 10889981187453 | Solid Polyaxial Screw, 6.5 x 90mm, Sm Stat |
| 10889981187446 | Solid Polyaxial Screw, 6.5 x 85mm, Sm Stat |
| 10889981187439 | Solid Polyaxial Screw, 6.5 x 80mm, Sm Stat |
| 10889981187422 | Solid Polyaxial Screw, 6.5 x 75mm, Sm Stat |
| 10889981187415 | Solid Polyaxial Screw, 6.5 x 60mm, Sm Stat |
| 10889981187408 | Solid Polyaxial Screw, 6.5 x 55mm, Sm Stat |
| 10889981187392 | Solid Polyaxial Screw, 6.5 x 50mm, Sm Stat |
| 10889981187385 | Solid Polyaxial Screw, 6.5 x 45mm, Sm Stat |
| 10889981187378 | Solid Polyaxial Screw, 6.5 x 40mm, Sm Stat |
| 10889981187361 | Solid Polyaxial Screw, 6.5 x 35mm, Sm Stat |
| 10889981187354 | Solid Polyaxial Screw, 6.5 x 30mm, Sm Stat |
| 10889981187347 | Solid Polyaxial Screw, 6.5 x 25mm, Sm Stat |
| 10889981187323 | Solid Polyaxial Screw, 6.5 x 110mm, Sm Stat |
| 10889981187316 | Solid Polyaxial Screw, 6.5 x 105mm, Sm Stat |
| 10889981187309 | Solid Polyaxial Screw, 6.5 x 100mm, Sm Stat |
| 10889981187293 | Solid Polyaxial Screw, 6.0 x 60mm, Sm Stat |
| 10889981187286 | Solid Polyaxial Screw, 6.0 x 55mm, Sm Stat |
| 10889981187279 | Solid Polyaxial Screw, 6.0 x 50mm, Sm Stat |
| 10889981187262 | Solid Polyaxial Screw, 6.0 x 45mm, Sm Stat |
| 10889981187255 | Solid Polyaxial Screw, 6.0 x 40mm, Sm Stat |
Trademark Results [Daytona]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DAYTONA 97111692 not registered Live/Pending |
Motiv Health Inc. 2021-11-05 |
 DAYTONA 90804897 not registered Live/Pending |
Nexgrill Industries, Inc. 2021-06-30 |
 DAYTONA 88281594 not registered Live/Pending |
MyoBlox LLC 2019-01-29 |
 DAYTONA 87296497 not registered Dead/Abandoned |
Bridgestone Brands, LLC 2017-01-11 |
 DAYTONA 86675719 not registered Dead/Abandoned |
Harbor Freight Tools USA, Inc. 2015-06-26 |
 DAYTONA 86572868 not registered Dead/Abandoned |
OPTOS PLC 2015-03-23 |
 DAYTONA 86232205 4750576 Live/Registered |
International Speedway Corporation 2014-03-26 |
 DAYTONA 85927829 4554558 Live/Registered |
BEDROSIAN, ROBERT 2013-05-09 |
 DAYTONA 85552141 4352482 Live/Registered |
SeaSpine, Inc. 2012-02-24 |
 DAYTONA 79342959 not registered Live/Pending |
DAYTONA CORPORATION 2022-04-28 |
 DAYTONA 79132422 4910615 Live/Registered |
Optos plc 2012-12-07 |
 DAYTONA 78964683 3734318 Live/Registered |
International Speedway, Inc. 2006-08-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.