SeptAlign (SPLN001)

Q: What is the product code of K260620?

The FDA product code is NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 874.3620.

FDA 510(k) K260620 · Spirair, Inc.

Substantially Equivalent

510(k) numberK260620

Submission

Device name: SeptAlign (SPLN001)
Applicant: Spirair, Inc.
South San Francisco, Ca, US
Received: February 25, 2026
Decision date: July 30, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device class: Class II (moderate risk)
Regulation: 21 CFR 874.3620
Specialty: Ear, Nose, Throat

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.

Other 510(k)s with product code NHB

510(k)	Device	Applicant	Decision
K251790	SeptAlignNHB · Traditional	Spirair, Inc.	01/16/2026SE
K233569	SeptAlignNHB · Traditional	Spirair, Inc.	03/22/2024SE
K223167	Spirair Nasal Septal StrapNHB · Traditional	Spirair, Inc.	08/17/2023SE
K210411	PosiSep EAR Fragmentable Ear DressingNHB · Traditional	Hemostasis, LLC	05/05/2022SE
K192661	LATERA Absorbable Nasal Implant SystemNHB · Special	Entellus Medical, Inc. (Aka Stryker Ent)	11/10/2019SE
K183015	PuraSinusNHB · Traditional	3-D Matrix, Inc.	04/12/2019SE
K161191	Latera Absorbable Nasal ImplantNHB · Special	Spirox, Inc.	06/23/2016SE
K152958	INEX Absorbable Nasal ImplantNHB · Traditional	Spirox, Inc.	12/04/2015SE
K132920	Spirox Inex DeviceNHB · Traditional	Spirox, Inc.	06/10/2014SE
K122434	Merogel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic GelNHB · Special	Medtronic Xomed	10/31/2012SE

More from Medtronic Xomed

510(k)	Device	Decision
K251790	SeptAlignNHB · Traditional	01/16/2026SE
K243655	TurbAlignLYA · Traditional	07/11/2025SE
K233569	SeptAlignNHB · Traditional	03/22/2024SE
K223167	Spirair Nasal Septal StrapNHB · Traditional	08/17/2023SE

Questions and answers

When was SeptAlign (SPLN001) cleared by the FDA?

SeptAlign (SPLN001) (K260620) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 155 days after the submission was received.

What is the product code of K260620?

The FDA product code is NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 874.3620.