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 a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-07-19 under approval 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. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K191648.
When was Mariner MIS Pedicle Screw System; SeaSpine Navigation System approved by the FDA?
Mariner MIS Pedicle Screw System; SeaSpine Navigation System received FDA 510(k) clearance on 2019-07-19, under approval number K191648.
What company makes Mariner MIS Pedicle Screw System; SeaSpine Navigation System?
Mariner MIS Pedicle Screw System; SeaSpine Navigation System is manufactured by SeaSpine Orthopedics Corporation.
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.
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Other Devices by SeaSpine Orthopedics Corporation
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K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161535SeaSpine® NewPort Spinal System
K160902Mariner Pedicle Screw System
K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
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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.