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FDA 510(k)

Neuromonitoring Kit

K-Number: K161893 · 2016-10-18

ApplicantSI-BONE, Inc.
Decision Date2016-10-18
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Neuromonitoring Kit is the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K161893. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuromonitoring Kit?

Neuromonitoring Kit is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is SI-BONE, Inc.. The 510(k) number is K161893.

When did Neuromonitoring Kit receive FDA 510(k) clearance?

Neuromonitoring Kit received FDA 510(k) clearance on 2016-10-18, under 510(k) number K161893.

Who is the listed applicant for Neuromonitoring Kit?

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

What is the FDA product code for Neuromonitoring Kit?

The FDA product code for Neuromonitoring Kit is PDQ.

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Related Devices (Code: PDQ)

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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