Shoreline™ ACS 86-0014

GUDID 10889987164557

Inserter With Stop, Spacer

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic rod reducer

• Primary Device ID: 10889987164557
• NIH Device Record Key: 87e8e324-36f1-45b3-a6dd-d31a586a6821
• Commercial Distribution Discontinuation: 2022-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Shoreline™ ACS
• Version Model Number: 86-0014
• Catalog Number: 86-0014
• 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
• 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	10889987164557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183083

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

[10889987164557]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-19
• Device Publish Date: 2019-08-20

On-Brand Devices [Shoreline™ ACS]

• 00889981142523: Interbody, 14x13x12mm, 10 Degree, Sterile
• 00889981142516: Interbody, 14x13x11mm, 10 Degree, Sterile
• 00889981142509: Interbody, 14x13x10mm, 10 Degree, Sterile
• 00889981142493: Interbody, 14x13x9mm, 10 Degree, Sterile
• 00889981142486: Interbody, 14x13x8mm, 10 Degree, Sterile
• 00889981142479: Interbody, 14x13x7mm, 10 Degree, Sterile
• 00889981142462: Interbody, 14x13x6mm, 10 Degree, Sterile
• 00889981142363: No Profile Spacer, 20x15x12mm, 7 Degree, Sterile
• 00889981142356: No Profile Spacer, 20x15x11mm, 7 Degree, Sterile
• 00889981142349: No Profile Spacer, 20x15x10mm, 7 Degree, Sterile
• 00889981142332: No Profile Spacer, 20x15x9mm, 7 Degree, Sterile
• 00889981142325: No Profile Spacer, 20x15x8mm, 7 Degree, Sterile
• 00889981142318: No Profile Spacer, 20x15x7mm, 7 Degree, Sterile
• 00889981142301: No Profile Spacer, 20x15x6mm, 7 Degree, Sterile
• 00889981124468: Interbody, 14x13x12mm, 7 Degree, Sterile
• 00889981124451: Interbody, 14x13x11mm, 7 Degree, Sterile
• 00889981124444: Interbody, 14x13x10mm, 7 Degree, Sterile
• 00889981124437: Interbody, 14x13x9mm, 7 Degree, Sterile
• 00889981124420: Interbody, 14x13x8mm, 7 Degree, Sterile
• 00889981124413: Interbody, 14x13x7mm, 7 Degree, Sterile
• 00889981124406: Interbody, 14x13x6mm, 7 Degree, Sterile
• 00889981124390: Interbody, 14x13x5mm, 7 Degree, Sterile
• 00889981124000: No Profile Spacer, 14x13x12mm, 7 Degree, Sterile
• 00889981123997: No Profile Spacer, 14x13x11mm, 7 Degree, Sterile
• 00889981123980: No Profile Spacer, 14x13x10mm, 7 Degree, Sterile
• 00889981123973: No Profile Spacer, 14x13x9mm, 7 Degree, Sterile
• 00889981123966: No Profile Spacer, 14x13x8mm, 7 Degree, Sterile
• 00889981123959: No Profile Spacer, 14x13x7mm, 7 Degree, Sterile
• 10889981183028: 7 Degree Modular Trial Caddy
• 10889981183011: Shoreline 14x13, 7 Degree Trial Tray
• 10889981183004: Shoreline Interbody Instrument Tray
• 10889981189235: Distraction Pin 14mm
• 10889981189228: Distraction Pin 12mm
• 10889981189211: Distraction Pin 10mm
• 10889981189204: Distraction Pin Nut
• 10889981189198: Distraction Pin Driver
• 10889987163130: Double Barrel DTS Guide
• 10889981143336: Packing Block
• 10889987164557: Inserter With Stop, Spacer
• 10889987164540: Inserter, Spacer
• 10889981285951: Screw Inserter Forced Tip
• 10889981285944: Screw Inserter - Split Tip