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FDA 510(k)

Latera Absorbable Nasal Implant

K-Number: K161191 · 2016-06-23

ApplicantSpirox, Inc.
Decision Date2016-06-23
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Latera Absorbable Nasal Implant is a medical device manufactured by Spirox, Inc.. It received FDA 510(k) clearance on 2016-06-23 under approval number K161191. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Latera Absorbable Nasal Implant?

Latera Absorbable Nasal Implant is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Spirox, Inc.. The 510(k) number is K161191.

When was Latera Absorbable Nasal Implant approved by the FDA?

Latera Absorbable Nasal Implant received FDA 510(k) clearance on 2016-06-23, under approval number K161191.

What company makes Latera Absorbable Nasal Implant?

Latera Absorbable Nasal Implant is manufactured by Spirox, Inc..

What is the FDA product code for Latera Absorbable Nasal Implant?

The FDA product code for Latera Absorbable Nasal Implant is NHB.

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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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