SeaSpine NewPort Spinal System

Thoracolumbosacral Pedicle Screw System

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Newport Spinal System.

Pre-market Notification Details

• Device ID: K180176
• 510k Number: K180176
• Device Name: SeaSpine NewPort Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 90228
• Contact: Gina Flores
• Correspondent: Gina Flores; SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 90228
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-22
• Decision Date: 2018-02-20
• Summary: summary

NIH GUDID Devices

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