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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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-09-07 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K222110.

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

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

Who is the listed applicant for Mariner RDX 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 RDX System?

The FDA product code for Mariner RDX 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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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