Skipjack 83-0010

GUDID 10889981139148

11mm x 30mm x 10-14mm, 0 Deg

SEASPINE ORTHOPEDICS CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 10889981139148
• NIH Device Record Key: 71692f47-6373-4c17-a823-3c7643dd73bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skipjack
• Version Model Number: 83-0010
• Catalog Number: 83-0010
• 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
• 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
• 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981139148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153786

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

[10889981139148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-29

On-Brand Devices [Skipjack]

• 10889981153854: Tower Release Guide
• 10889981144364: Skipjack Expandable Interbody System
• 10889981144357: Skipjack Bone Graft Delivery Instruments
• 10889981140038: 10mm x 28mm x 12mm, 6-20 Deg
• 10889981140021: 10mm x 28mm x 10mm, 3-17 Deg
• 10889981140014: 10mm x 28mm x 8mm, 0-14 Deg
• 10889981140007: 10mm x 26mm x 12mm, 6-20 Deg
• 10889981139995: 10mm x 26mm x 10mm, 3-17 Deg
• 10889981139988: 10mm x 26mm x 8mm, 0-14 Deg
• 10889981139971: 11mm x 28mm x 12-16mm, 6 Deg
• 10889981139964: 11mm x 28mm x 10-14mm, 6 Deg
• 10889981139957: 11mm x 28mm x 12-16mm, 0 Deg
• 10889981139940: 11mm x 28mm x 10-14mm, 0 Deg
• 10889981139933: 11mm x 28mm x 8-12mm, 0 Deg
• 10889981139926: 11mm x 26mm x 12-15mm, 6 Deg
• 10889981139919: 11mm x 26mm x 10-13mm, 6 Deg
• 10889981139902: 11mm x 26mm x 12-15mm, 0 Deg
• 10889981139896: 11mm x 26mm x 10-13mm, 0 Deg
• 10889981139889: 11mm x 26mm x 8-11mm, 0 Deg
• 10889981139704: Palm Handle Torque Limiting Driver AO 2.5 Nm
• 10889981139179: 11mm x 30mm x 12-16mm, 6 Deg
• 10889981139162: 11mm x 30mm x 10-14mm, 6 Deg
• 10889981139155: 11mm x 30mm x 12-16mm, 0 Deg
• 10889981139148: 11mm x 30mm x 10-14mm, 0 Deg
• 10889981139131: 11mm x 30mm x 8-12mm, 0 Deg
• 10889981139124: 10mm x 32mm x 12mm, 6-20 Deg
• 10889981139117: 10mm x 32mm x 10mm, 3-17 Deg
• 10889981139100: 10mm x 32mm x 8mm, 0-14 Deg
• 10889981139087: Starter Trial 6mm
• 10889981139070: Bone Delivery Sterilization Tray
• 10889981139063: Implant Caddy
• 10889981139056: Sterilization Tray
• 10889981139049: Bone Cartridge Funnel
• 10889981139032: Bone Cartridge Pusher
• 10889981139025: Bone Cartridge Holder
• 10889981139018: Bone Cartridge
• 10889981139001: Bone Delivery T-Handle
• 10889981138998: Bone Delivery Rack Plunger
• 10889981138981: Bone Delivery Assembly
• 10889981138967: Bone Mill T-Handle
• 10889981138950: Bone Mill Collector
• 10889981138943: Bone Mill Grater
• 10889981138936: Bone Mill
• 10889981138929: Trial 12mm
• 10889981138912: Trial 10mm
• 10889981138905: Trial 8mm
• 10889981138899: T Handle with1/4’’ Square Adapter
• 10889981138882: Slap Hammer
• 10889981138875: MP Wrench
• 10889981138868: Implant Removal Tool