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FDA 510(k)

Mariner Outrigger Revision System

K-Number: K183639 · 2019-05-23

ApplicantSeaSpine Orthopedics Corporation
Decision Date2019-05-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mariner Outrigger Revision System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-05-23 under approval number K183639. 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 Mariner Outrigger Revision System?

Mariner Outrigger Revision System is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K183639.

When was Mariner Outrigger Revision System approved by the FDA?

Mariner Outrigger Revision System received FDA 510(k) clearance on 2019-05-23, under approval number K183639.

What company makes Mariner Outrigger Revision System?

Mariner Outrigger Revision System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Mariner Outrigger Revision System?

The FDA product code for Mariner Outrigger Revision System is NKB.

Related Clinical Trials

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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.

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