SeaSpine NewPort Spinal System
K-Number: K180176 · 2018-02-20
ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-02-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SeaSpine NewPort Spinal System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2018-02-20 under approval number K180176. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeaSpine NewPort Spinal System?
SeaSpine NewPort Spinal System is a medical device that received FDA 510(k) clearance on 2018-02-20. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K180176.
When was SeaSpine NewPort Spinal System approved by the FDA?
SeaSpine NewPort Spinal System received FDA 510(k) clearance on 2018-02-20, under approval number K180176.
What company makes SeaSpine NewPort Spinal System?
SeaSpine NewPort Spinal System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine NewPort Spinal System?
The FDA product code for SeaSpine NewPort Spinal System is NKB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.