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Spirox INEX Device

by Spirox, Inc.

510(k) K132920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132920 Date10 Jun 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NHB
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Spirox INEX Device is an absorbable, perforated implantable sheet made of poly (L-lactide) 70:30, indicated for supporting nasal septal cartilage. It is designed to be implanted by surgeons using standard surgical tools and techniques. The device is provided as a sterile, single-use sheet measuring 24.5 x 20.0 mm and 1.1 mm thick.

The Spirox INEX Device is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance with product code NHB. It is classified as a Class II device and is intended for prescription use. The device is manufactured by Spirox, Inc. and has received FDA clearance for supporting nasal upper and lower cartilage.

Other devices from Spirox, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Spirox INEX Device used for?

    The Spirox INEX Device is indicated for supporting nasal septal cartilage, providing structural support to both upper and lower nasal cartilage during healing after implantation by a surgeon using standard surgical tools.

  • How is the Spirox INEX Device supplied and is it sterile?

    The device is supplied as a sterile, single-use implantable sheet, packaged to maintain sterility until point of use, ensuring it is ready for implantation without additional sterilization by the healthcare provider.

  • What are the dimensions and material of the Spirox INEX Device?

    The Spirox INEX Device is an absorbable perforated sheet made of poly(L-lactide) 70:30, with dimensions of 24.5 mm in length, 20.0 mm in width, and 1.1 mm in thickness, designed for precise placement in nasal septal support applications.

  • Is the Spirox INEX Device reusable or single-use?

    The Spirox INEX Device is designated for single-use only; it is implanted once and not intended for retrieval, cleaning, or reimplantation due to its absorbable nature and sterile single-use packaging.

  • What regulatory pathway was used for the Spirox INEX Device?

    The Spirox INEX Device received regulatory clearance through the FDA 510(k) process under product code NHB, demonstrating substantial equivalence to a legally marketed predicate device for its intended use in nasal septal support.