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FDA 510(k)

Mariner MIS Pedicle Screw System; SeaSpine Navigation System

K-Number: K191648 · 2019-07-19

ApplicantSeaSpine Orthopedics Corporation
Decision Date2019-07-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mariner MIS Pedicle Screw System; SeaSpine Navigation 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 2019-07-19 under 510(k) number K191648. 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 MIS Pedicle Screw System; SeaSpine Navigation System?

Mariner MIS Pedicle Screw System; SeaSpine Navigation System is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K191648.

When did Mariner MIS Pedicle Screw System; SeaSpine Navigation System receive FDA 510(k) clearance?

Mariner MIS Pedicle Screw System; SeaSpine Navigation System received FDA 510(k) clearance on 2019-07-19, under 510(k) number K191648.

Who is the listed applicant for Mariner MIS Pedicle Screw System; SeaSpine Navigation 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 MIS Pedicle Screw System; SeaSpine Navigation System?

The FDA product code for Mariner MIS Pedicle Screw System; SeaSpine Navigation System is NKB.

Related Clinical Trials

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.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

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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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