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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 the device name listed in this FDA 510(k) record. The listed applicant is Indius Medical Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2020-10-26 under 510(k) 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. The listed applicant is Indius Medical Technologies Pvt. , Ltd.. The 510(k) number is K200937.

When did ACURA Stabilization System receive FDA 510(k) clearance?

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

Who is the listed applicant for ACURA Stabilization System?

The FDA 510(k) record lists Indius Medical Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACURA Stabilization System?

The FDA product code for ACURA Stabilization System is NKB.

Other records listing Indius Medical Technologies Pvt. , Ltd. as applicant

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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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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