Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)

Q: What is the product code of K253580?

The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.

FDA 510(k) K253580 · Tedan Surgical Innovations

Substantially Equivalent

510(k) numberK253580

Submission

Device name: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Applicant: Tedan Surgical Innovations
Sugar Land, TX, US
Received: November 17, 2025
Decision date: April 26, 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: PDQ – Neurosurgical Nerve Locator
Device class: Class II (moderate risk)
Regulation: 21 CFR 874.1820
Specialty: Ear, Nose, Throat

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

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K223438	TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ · Traditional	Medos International SARL	02/10/2023SE
K221821	ATEC IOM Accessory InstrumentsPDQ · Traditional	Alphatec Spine, Inc.	09/23/2022SE
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K201454	DSG Connect TechnologyPDQ · Traditional	Spineguard S.A.	02/10/2021SE
K191723	ATEC IOM Accessory InstrumentsPDQ · Traditional	Alphatec Spine, Inc.	10/18/2019SE
K190163	ALARA Neuro Access KitPDQ · Traditional	SurGenTec, LLC	07/16/2019SE
K182617	ATEC IOM Accessory InstrumentsPDQ · Traditional	Alphatec Spine, Inc.	05/09/2019SE

More from Alphatec Spine, Inc.

510(k)	Device	Decision
K231691	Phantom XL Insulated DilatorsGXZ · Special	06/29/2023SE
K161318	Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional	03/20/2017SE
K140088	Phantom XL Insulated DilatorsPDQ · Traditional	09/25/2014SE

Questions and answers

When was Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) cleared by the FDA?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (K253580) received a 510(k) decision of Substantially Equivalent on April 26, 2026, 160 days after the submission was received.

What is the product code of K253580?

The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.