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FDA 510(k)

DualX

K-Number: K181397 · 2018-09-27

ApplicantInnovasive, Inc.
Decision Date2018-09-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DualX is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive, Inc.. It received FDA 510(k) clearance on 2018-09-27 under 510(k) number K181397. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DualX?

DualX is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Innovasive, Inc.. The 510(k) number is K181397.

When did DualX receive FDA 510(k) clearance?

DualX received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181397.

Who is the listed applicant for DualX?

The FDA 510(k) record lists Innovasive, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DualX?

The FDA product code for DualX is MAX.

Related Devices (Code: MAX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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