Daytona 76-2100

GUDID 10889981131487

Straight Rod, 4.5 x 100mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981131487
• NIH Device Record Key: 877d56a5-3cae-45e3-98ec-519c3fc47d2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daytona
• Version Model Number: 76-2100
• Catalog Number: 76-2100
• 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
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981131487 [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

[10889981131487]

Moist Heat or Steam Sterilization

[10889981131487]

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