Specials SR-0580

GUDID 10889981257422

Modified Navigation Mariner Screw Shank Driver

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant driver

• Primary Device ID: 10889981257422
• NIH Device Record Key: 19a508bf-fd62-4603-884a-89f8e8f7e50a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Specials
• Version Model Number: SR-0580
• Catalog Number: SR-0580
• 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: 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

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981257422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172517

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

[10889981257422]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-10-19

On-Brand Devices [Specials]

• 10889994170480: Rod Rocker
• 10889987170749: Double Barrel Drill Guide
• 10889987170732: Angled Cobb
• 10889987170411: Offset Clip
• 10889987170398: 4mm Driver
• 10889987170336: Large Dilator
• 10889987170329: Locking Medium Dilator
• 10889987170312: Locking Set Screw Inserter
• 10889987164847: Lamina Spreader
• 10889987164830: 6.0mm Coronal Benders, Right
• 10889987164823: 6.0mm Coronal Benders, Left
• 10889987164816: 6.0mm Benders, Right
• 10889987164809: 6.0mm Benders, Left
• 10889987164724: Mariner tab breaker for Malibu
• 10889987164533: ALIF Parallel Distractor
• 10889987164434: Split Tip Hex Driver, 4mm
• 10889987164427: Screw Seat Adjuster
• 10889987164410: Mariner extended turn key 2
• 10889987164403: Mariner extended turn key 1
• 10889987163574: Trial w/o stop 16x14x12mm, 7 Deg
• 10889987163567: Trial w/o stop 16x14x11mm, 7 Deg
• 10889987163550: Trial w/o stop 16x14x10mm, 7 Deg
• 10889987163543: Trial w/o stop 16x14x09mm, 7 Deg
• 10889987163536: Trial w/o stop 16x14x08mm, 7 Deg
• 10889987163529: Trial w/o stop 16x14x07mm, 7 Deg
• 10889987163512: Trial w/o stop 16x14x06mm, 7 Deg
• 10889987163505: Trial w/o stop 16x14x05mm, 7 Deg
• 10889987163369: T-Handled Malibu Straight Probe
• 10889987163314: Bridge Caliper 6.0
• 10889987163161: 30° Angled, Rotated 90° Teardop Curette, 6mm
• 10889987163154: 45° Angled Teardop Curette, 6mm
• 10889987163147: Straight Teardop Curette, 6mm
• 10889985163088: Locking Screw Inserter Sleeve
• 10889984163072: Single Action Persuader
• 10889982163050: Syringe Tip Pusher
• 10889981257163: Crossbar Counter Torque
• 10889981256982: Dilator 5, Threaded
• 10889981256975: Dilator 4, Threaded
• 10889981256968: Dilator 3, Threaded
• 10889981256951: Dilator 2, Threaded
• 10889981256357: Coronal Bender Ø3.5mm/4.0mm, Right
• 10889981256340: Coronal Bender Ø3.5mm/4.0mm, Left
• 10889981255961: Solid Tap, Tri-Flat, 9.50mm
• 10889981255954: Solid Tap, Tri-Flat, 8.50mm
• 10889981255947: Solid Tap, Tri-Flat, 7.50mm
• 10889981255930: Solid Tap, Tri-Flat, 6.50mm
• 10889981255923: Solid Tap, Tri-Flat, 5.50mm
• 10889981255916: Solid Tap, Tri-Flat, 4.50mm
• 10889981255909: Pedicle Screw Driver, Locking, Tri-Flat
• 10889981255893: Set Screw Starter, Tri-Flat