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: K161535
• 510k Number: K161535
• Device Name: SeaSpine® NewPort™ Spinal System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008
• Contact: Michelle Willis
• Correspondent: Gina Flores; SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE Carlsbad, CA 92008
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-03
• Decision Date: 2016-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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