Shoreline 86-0012

GUDID 10889981162696

Inserter, Straight

SEASPINE ORTHOPEDICS CORPORATION

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

• Primary Device ID: 10889981162696
• NIH Device Record Key: 616895a3-c665-48b5-9214-a6e500469a0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoreline
• Version Model Number: 86-0012
• Catalog Number: 86-0012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981162696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161081

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10889981162696]

Moist Heat or Steam Sterilization

[10889981162696]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-01-09

On-Brand Devices [Shoreline]

• 10889981176365: Angled Awl, 12mm
• 10889981162696: Inserter, Straight
• 10889981155186: Angled Awl, 12mm