NHB
- 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.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260620 | 2026-07-30 | Spirair, Inc. | SeptAlign (SPLN001) | |
| K251790 | 2026-01-16 | Spirair, Inc. | SeptAlign | |
| K233569 | 2024-03-22 | Spirair, Inc. | SeptAlign |
Official FDA classification page: NHB
Classification and pathway per current FDA publications. Data from openFDA (CC0).