Shoreline ASC 86-9905

GUDID 10889981127695

Shoreline DTS Guide Tray

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981127695
• NIH Device Record Key: 619ba43f-4d3e-4e27-9bec-e4960469d47f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoreline ASC
• Version Model Number: 86-9905
• Catalog Number: 86-9905
• 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	10889981127695 [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

[10889981127695]

Moist Heat or Steam Sterilization

[10889981127695]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-30

On-Brand Devices [Shoreline ASC]

• 10889981140342: 12mm, Locking Cover, Backup
• 10889981140335: 11mm, Locking Cover, Backup
• 10889981140328: 10mm, Locking Cover, Backup
• 10889981140311: 9mm, Locking Cover, Backup
• 10889981140304: 8mm, Locking Cover, Backup
• 10889981140298: 7mm, Locking Cover, Backup
• 10889981140281: 6mm, Locking Cover, Backup
• 10889981140274: 5mm, Locking Cover, Backup
• 10889981137496: DTS Drill, 14mm
• 10889981137489: DTS Drill, 12mm
• 10889981137472: Inserter With Stop
• 10889981137465: 4.0mm Fixed Angle Screw, Self Tapping, 20mm
• 10889981137458: 4.0mm Variable Screw, Self Tapping, 20mm
• 10889981137441: 3.5mm Fixed Angle Screw, Self-Drilling, 20mm
• 10889981137434: 3.5mm Variable Screw, Self-Drilling, 20mm
• 10889981137427: 3.5mm Fixed Angle Screw, Self-Tapping, 20mm
• 10889981137410: 3.5mm Variable Screw, Self-Tapping, 20mm
• 10889981136215: 10° Ultra Low Profile Interbody Caddy
• 10889981135041: Rasp Head
• 10889981135034: Rasp
• 10889981132637: Trial 14x13x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132620: Trial 14x13x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132613: Trial 14x13x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132606: Trial 14x13x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132590: Trial 14x13x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132583: Trial 14x13x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981132576: Trial 14x13x6mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130428: Trial 20x15x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130411: Trial 20x15x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130404: Trial 20x15x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130398: Trial 20x15x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130381: Trial 20x15x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130374: Trial 20x15x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130367: Trial 20x15x6mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130350: Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130343: Trial 18x15x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130336: Trial 18x15x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130329: Trial 18x15x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130312: Trial 18x15x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130305: Trial 18x15x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130299: Trial 18x15x6mm, 10 Deg Lordosis, w/ Depth Sto
• 10889981130282: Trial 16x14x12mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130275: Trial 16x14x11mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130268: Trial 16x14x10mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130251: Trial 16x14x9mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130244: Trial 16x14x8mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130237: Trial 16x14x7mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130220: Trial 16x14x6mm, 10 Deg Lordosis, w/ Depth Stop
• 10889981130213: 20x15x6mm, 10 Degree, Interbody
• 10889981130206: 18x15x6mm, 10 Degree, Interbody