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FDA 510(k)

Meridian Anterior Plate System, Regatta Lateral Plate System

K-Number: K200885 · 2020-05-28

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-05-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Meridian Anterior Plate System, Regatta Lateral Plate System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-05-28 under approval number K200885. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meridian Anterior Plate System, Regatta Lateral Plate System?

Meridian Anterior Plate System, Regatta Lateral Plate System is a medical device that received FDA 510(k) clearance on 2020-05-28. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K200885.

When was Meridian Anterior Plate System, Regatta Lateral Plate System approved by the FDA?

Meridian Anterior Plate System, Regatta Lateral Plate System received FDA 510(k) clearance on 2020-05-28, under approval number K200885.

What company makes Meridian Anterior Plate System, Regatta Lateral Plate System?

Meridian Anterior Plate System, Regatta Lateral Plate System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Meridian Anterior Plate System, Regatta Lateral Plate System?

The FDA product code for Meridian Anterior Plate System, Regatta Lateral Plate System is KWQ.

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Related Devices (Code: KWQ)

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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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