Daytona 78-6530
GUDID 10889981132064
MONOAXIAL SCREW, 6.5 Dia. x 30mm SMALL STATURE
SEASPINE ORTHOPEDICS CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 10889981132064 |
| NIH Device Record Key | 9f5f4627-2600-4ee4-9e7f-e86f166c833a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Daytona |
| Version Model Number | 78-6530 |
| Catalog Number | 78-6530 |
| 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 Dimensions
| 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 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 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889981132064 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163604
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
[10889981132064]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-21 |
On-Brand Devices [Daytona]
| 10889981141066 | Small Stature Instrument Tray 2, Level 2 |
| 10889981141059 | Small Stature Instrument Tray 2, Level 1 |
| 10889981141042 | Small Stature Instrument Tray 2, Base |
| 10889981141035 | Small Stature Instrument Tray 1, Level 2 |
| 10889981141028 | Small Stature Instrument Tray 1, Level 1 |
| 10889981141011 | Small Stature Instrument Tray 1, Base |
| 10889981141004 | Small Stature Implant Tray, Level 2 |
| 10889981140991 | Small Stature Implant Tray, Level 1 |
| 10889981140984 | Small Stature Implant Tray, Lateral Connector Caddy |
| 10889981140977 | Small Stature Implant Tray, Rod Connector Caddy |
| 10889981140960 | Small Stature Implant Tray, Ti Cap Caddy |
| 10889981140953 | Small Stature Implant Tray, CoCr Cap Caddy |
| 10889981139681 | Small Stature Implant Tray, Screw Caddy |
| 10889981139674 | Small Stature Implant Tray, Base |
| 10889981139667 | Small Stature Tray Lid, Universal |
| 10889981139650 | Tap 7.5mm, Cannulated (for 8.0mm Screw) |
| 10889981139643 | Tap 6.5mm, Cannulated (for 7.0mm Screw) |
| 10889981139636 | Mono Screw Inserter, Small Stature |
| 10889981139629 | Sliding Lock, .193 Shaft |
| 10889981139612 | Locking Driver Free Sleeve, Small Stature |
| 10889981139605 | Split Hex Loader, One Piece, Blue |
| 10889981139599 | Coronal Bender, Fulcrum, Small Stature |
| 10889981139582 | 1/4" Square 4mm Driver, Small Stature |
| 10889981139575 | Torque Limiting Driver, 1/4 sq., 90 in-lb |
| 10889981139216 | Thoracic Sounding Probe - Straight |
| 10889981139209 | Pedicle Sounding Probe - Curved |
| 10889981139193 | Rod Template, 3.5mm DIA |
| 10889981139186 | Distractor, 4.5mm Dia |
| 10889981138707 | Coronal Bender 4.5mm Dia., Right |
| 10889981138691 | Coronal Bender 4.5mm Dia., Left |
| 10889981138684 | Rod Gripper, 4.5mm Dia. |
| 10889981138578 | Tap 8.0mm, Cannulated (for 8.5mm Screw) |
| 10889981138561 | Tap 7.0mm, Cannulated (for 7.5mm Screw) |
| 10889981138554 | Tap 6.0mm, Cannulated (for 6.5mm Screw) |
| 10889981138547 | Tap 5.5mm, Cannulated (for 6.0mm Screw) |
| 10889981138530 | Tap 5.0mm, Cannulated (for 5.5mm Screw) |
| 10889981138523 | Tap 4.5mm, Cannulated (for 5.0mm Screw) |
| 10889981138516 | Tap 4.0mm, Cannulated (for 4.5mm Screw) |
| 10889981138509 | Head Turner, Small Stature |
| 10889981138318 | Combination Wrench, 4.5mm Rod |
| 10889981138219 | Locking Driver Sleeve, Small Stature |
| 10889981138202 | Locking Driver Shaft, Small Stature |
| 10889981138172 | Daytona Small Stature Tab Breaker |
| 10889981136239 | Compressor, 4.5MM Dia |
| 10889981136222 | Counter Torque, Small Stature |
| 10889981132569 | MONOAXIAL SCREW, 8.5 Dia. x 110mm SMALL STATURE |
| 10889981132552 | MONOAXIAL SCREW, 8.5 Dia. x 105mm SMALL STATURE |
| 10889981132545 | MONOAXIAL SCREW, 8.5 Dia. x 100mm SMALL STATURE |
| 10889981132538 | MONOAXIAL SCREW, 8.5 Dia. x 95mm SMALL STATURE |
| 10889981132521 | MONOAXIAL SCREW, 8.5 Dia. x 90mm SMALL STATURE |
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 |
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