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FDA 510(k)

Mariner RDX System

K-Number: K222110 · 2022-09-07

ApplicantSeaSpine Orthopedics Corporation
Decision Date2022-09-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mariner RDX System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-09-07 under approval number K222110. 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 RDX System?

Mariner RDX System is a medical device that received FDA 510(k) clearance on 2022-09-07. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K222110.

When was Mariner RDX System approved by the FDA?

Mariner RDX System received FDA 510(k) clearance on 2022-09-07, under approval number K222110.

What company makes Mariner RDX System?

Mariner RDX System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Mariner RDX System?

The FDA product code for Mariner RDX System is NKB.

Other Devices by SeaSpine Orthopedics Corporation

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K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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