Shoreline ACS 86-0013

GUDID 10889981164546

Inserter, Spacer

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10889981164546
• NIH Device Record Key: 3aeb4872-93f8-4050-a505-c0a1121e3dc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoreline ACS
• Version Model Number: 86-0013
• Catalog Number: 86-0013
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981164546 [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

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

[10889981164546]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-01
• Device Publish Date: 2022-05-24

On-Brand Devices [Shoreline ACS]

• 10889981162573: Tap, 20mm
• 10889981162566: Tap, 18mm
• 10889981162559: Tap, 10mm
• 10889981162542: Drill, 20mm
• 10889981162535: Drill, 18mm
• 10889981162528: Drill, 10mm
• 10889981161996: Tray, Trials and Rasp Tray
• 10889981161989: Tray, Screw Prep and Final Tightening
• 10889981161972: Tray, Plates, Screws, and Locking Covers
• 10889981161965: Case Lid
• 10889981161958: Case, Shoreline Instrument and Fixation Tray
• 10889981149635: Shoreline Hyperlordotic Modular Trial Tray
• 10889981149499: Plate Assembly Tool
• 10889981149277: Plate Template
• 10889981146382: Angled DTS Awl
• 10889981146375: Angled DTS Driver
• 10889981144982: 15° Modular Trial Caddy
• 10889981144975: 10° Modular Trial Caddy
• 10889981144968: Shoreline Hyperlordotic Instrument Tray
• 10889981144852: Modular Trial 20x15x12mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144845: Modular Trial 20x15x11mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144838: Modular Trial 20x15x10mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144821: Modular Trial 20x15x9mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144814: Modular Trial 20x15x8mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144807: Modular Trial 18x15x12mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144791: Modular Trial 18x15x11mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144784: Modular Trial 18x15x10mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144777: Modular Trial 18x15x9mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144760: Modular Trial 18x15x8mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144753: Modular Trial 16x14x12mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144746: Modular Trial 16x14x11mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144739: Modular Trial 16x14x10mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144722: Modular Trial 16x14x9mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144715: Modular Trial 16x14x8mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144708: Modular Trial 16x14x7mm, 15 Deg Lordosis, w/ Depth Stop
• 10889981144692: Modular Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144685: Modular Trial 20x15x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144678: Modular Trial 20x15x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144661: Modular Trial 20x15x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144654: Modular Trial 20x15x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144647: Modular Trial 20x15x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144630: Modular Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144623: Modular Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144616: Modular Trial 18x15x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144609: Modular Trial 18x15x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144593: Modular Trial 18x15x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144586: Modular Trial 18x15x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144579: Modular Trial 18x15x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144562: Modular Trial 18x15x6mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981144555: Modular Trial 16x14x12mm, 10 Deg Lordosis, w/ Depth Stop