Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Spirox, Inc.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) 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. The listed applicant is Spirox, Inc.. The 510(k) number is K161191.

When did Latera Absorbable Nasal Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Latera Absorbable Nasal Implant?

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

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

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

Related Devices (Code: NHB)

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.

K260620SeptAlign (SPLN001)Spirair, Inc.K251790SeptAlignSpirair, Inc.K233569SeptAlignSpirair, Inc.K223167Spirair Nasal Septal StrapSpirair, Inc.K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLCK192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent)

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.

↑