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FDA 510(k)

ACURA Stabilization System

K-Number: K200937 · 2020-10-26

ApplicantIndius Medical Technologies Pvt. , Ltd.
Decision Date2020-10-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACURA Stabilization System is a medical device manufactured by Indius Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-10-26 under approval number K200937. 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 ACURA Stabilization System?

ACURA Stabilization System is a medical device that received FDA 510(k) clearance on 2020-10-26. It is manufactured by Indius Medical Technologies Pvt. , Ltd.. The 510(k) number is K200937.

When was ACURA Stabilization System approved by the FDA?

ACURA Stabilization System received FDA 510(k) clearance on 2020-10-26, under approval number K200937.

What company makes ACURA Stabilization System?

ACURA Stabilization System is manufactured by Indius Medical Technologies Pvt. , Ltd..

What is the FDA product code for ACURA Stabilization System?

The FDA product code for ACURA Stabilization System is NKB.

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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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