NHB

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Product code
NHB
Device name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device class
Class 2
21 CFR
21 CFR 874.3620
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
510(k) clearances (last 3 years)
16

FDA classification definition

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-30.

NumberDecision dateApplicantDevice nameSummary
K2606202026-07-30Spirair, Inc.SeptAlign (SPLN001)PDF
K2517902026-01-16Spirair, Inc.SeptAlignPDF
K2335692024-03-22Spirair, Inc.SeptAlignPDF

3 summaries are archived here for direct download.

Official FDA classification page: NHB
Classification and pathway per current FDA publications. Data from openFDA (CC0).