NorthStar PC1-514020

GUDID 10889981198848

Straight CoCr Rod, 4.0mm x 200mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981198848
• NIH Device Record Key: 4abe1bf6-4e12-4cc4-b03e-34f047436ab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NorthStar
• Version Model Number: PC1-514020
• Catalog Number: PC1-514020
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981198848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193615

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

[10889981198848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [NorthStar]

• 10889981231750: W Dual, Parallel, Top Loading to 5.5/6.0mm
• 10889981231743: W Dual, Parallel, Top Loading
• 10889981231736: W Parallel Top Loading to 5.5/6.0mm
• 10889981231729: W Parallel Top Loading
• 10889981221010: Transition Tray Bottom Level Insert
• 10889981217280: Transition CoCr Rod, 4.0mm to 6.0mm, 500mm
• 10889981217273: Transition CoCr Rod, 4.0mm to 5.5mm, 500mm
• 10889981217266: Transition CoCr Rod, 3.5mm to 6.0mm, 500mm
• 10889981217259: Transition CoCr Rod, 3.5mm to 5.5mm, 500mm
• 10889981214265: Rod-to-Rod Connector, 4.0mm XL
• 10889981214258: Rod-to-Rod Connector, 3.5mm XL
• 10889981200220: Transition Tray Top Level Insert
• 10889981200206: Transition Tray Case
• 10889981200190: Implant Tray Insert
• 10889981200152: Implant Tray Case
• 10889981200145: Instrument Tray Top Level Insert
• 10889981200121: Instrument Tray Bottom Level Insert
• 10889981200107: Instrument Tray Case
• 10889981200091: Occ Tray Insert
• 10889981200077: OCC Tray Case
• 10889981200060: Transition Implant Caddy
• 10889981200053: 5.5mm Favored Angle Screw Caddy
• 10889981200046: 4.5mm Favored Angle Screw Caddy
• 10889981200039: 3.5mm/4.0mm Extended Tab Screw Caddy
• 10889981200022: 4.0mm Contoured Rod Caddy
• 10889981200015: 3.5mm Contoured Rod Caddy
• 10889981199999: Rod to Screw Connector Caddy
• 10889981199982: Screw to Screw Connector Caddy
• 10889981199975: Set Screw Caddy
• 10889981199968: 3.5mm Smooth Shank Screw Caddy
• 10889981199951: 4.0mm Poly Screw Caddy
• 10889981199944: 3.5mm Poly Screw Caddy
• 10889981199920: OCC Plate Caddy
• 10889981199913: OCC Screw Caddy
• 10889981199043: Transition Ti Rod, 4.0mm to 6.0mm, 500mm
• 10889981199036: Transition Ti Rod, 4.0mm to 5.5mm, 500mm
• 10889981199029: Transition Ti Rod, 3.5mm to 6.0mm, 500mm
• 10889981199012: Transition Ti Rod, 3.5mm to 5.5mm, 500mm
• 10889981199005: Contoured CoCr OCC Rod, 4.0mm x 170mm x 70 Deg
• 10889981198992: Contoured CoCr OCC Rod, 4.0mm x 170mm x 60 Deg
• 10889981198985: Contoured CoCr Rod, 4.0mm x 95mm
• 10889981198978: Contoured CoCr Rod, 4.0mm x 90mm
• 10889981198961: Contoured CoCr Rod, 4.0mm x 85mm
• 10889981198954: Contoured CoCr Rod, 4.0mm x 80mm
• 10889981198947: Contoured CoCr Rod, 4.0mm x 75mm
• 10889981198930: Contoured CoCr Rod, 4.0mm x 70mm
• 10889981198923: Contoured CoCr Rod, 4.0mm x 65mm
• 10889981198916: Contoured CoCr Rod, 4.0mm x 60mm
• 10889981198909: Contoured CoCr Rod, 4.0mm x 55mm
• 10889981198893: Contoured CoCr Rod, 4.0mm x 50mm