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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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-05-23 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K183639.

When did Mariner Outrigger Revision System receive FDA 510(k) clearance?

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

Who is the listed applicant for Mariner Outrigger Revision System?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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