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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-08-05 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K201240.

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

Mariner Cap System received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201240.

Who is the listed applicant for Mariner Cap 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 Cap System?

The FDA product code for Mariner Cap System is OWI.

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Related Devices (Code: OWI)

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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, 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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