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
10889981138813	K161535	000
10889981125585	K161535	000
10889981125578	K161535	000
10889981125561	K161535	000
10889981125554	K161535	000
10889981125547	K161535	000
10889981125530	K161535	000
10889981125523	K161535	000
10889981125516	K161535	000
10889981030674	K161535	000
10889981030667	K161535	000
10889981030551	K161535	000
10889981125592	K161535	000
10889981125608	K161535	000
10889981138806	K161535	000
10889981138790	K161535	000
10889981138783	K161535	000
10889981138776	K161535	000
10889981125677	K161535	000
10889981125660	K161535	000
10889981125653	K161535	000
10889981125646	K161535	000
10889981125639	K161535	000
10889981125622	K161535	000
10889981125615	K161535	000
10889981030360	K161535	000