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FDA 510(k)

SEA-LINK Anterior Cervical Plate System

K-Number: K200224 · 2020-03-24

ApplicantIndius Medical Technologies Pvt. , Ltd.
Decision Date2020-03-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEA-LINK Anterior Cervical Plate System is a medical device manufactured by Indius Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-03-24 under approval number K200224. 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 SEA-LINK Anterior Cervical Plate System?

SEA-LINK Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-03-24. It is manufactured by Indius Medical Technologies Pvt. , Ltd.. The 510(k) number is K200224.

When was SEA-LINK Anterior Cervical Plate System approved by the FDA?

SEA-LINK Anterior Cervical Plate System received FDA 510(k) clearance on 2020-03-24, under approval number K200224.

What company makes SEA-LINK Anterior Cervical Plate System?

SEA-LINK Anterior Cervical Plate System is manufactured by Indius Medical Technologies Pvt. , Ltd..

What is the FDA product code for SEA-LINK Anterior Cervical Plate System?

The FDA product code for SEA-LINK Anterior Cervical Plate System is KWQ.

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Other Devices by Indius Medical Technologies Pvt. , Ltd.

K200937ACURA Stabilization System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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