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FDA 510(k)

Mariner Pedicle Screw System

K-Number: K212692 · 2021-09-21

ApplicantSeaSpine Orthopedics Corporation
Decision Date2021-09-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mariner Pedicle Screw 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 2021-09-21 under 510(k) number K212692. 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 Pedicle Screw System?

Mariner Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2021-09-21. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K212692.

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

Mariner Pedicle Screw System received FDA 510(k) clearance on 2021-09-21, under 510(k) number K212692.

Who is the listed applicant for Mariner Pedicle Screw 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 Pedicle Screw System?

The FDA product code for Mariner Pedicle Screw 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.

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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.

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