Mariner Cap System
K-Number: K201240 · 2020-08-05
ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-08-05
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Mariner Cap System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-08-05 under approval number K201240. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mariner Cap System?
Mariner Cap System is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K201240.
When was Mariner Cap System approved by the FDA?
Mariner Cap System received FDA 510(k) clearance on 2020-08-05, under approval number K201240.
What company makes Mariner Cap System?
Mariner Cap System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for Mariner Cap System?
The FDA product code for Mariner Cap System is OWI.
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K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
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K160902Mariner Pedicle Screw System
K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
Related Devices (Code: OWI)
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.