Mainz Head Fixation by Perneczky

Q: What is the product code of K901393?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.

FDA 510(k) K901393 · Zeppelin GmbH

Substantially Equivalent

510(k) numberK901393

Submission

Device name: Mainz Head Fixation by Perneczky
Applicant: Zeppelin GmbH
West Germany, DE
Received: March 26, 1990
Decision date: September 4, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4460
Specialty: Neurology

Other 510(k)s with product code HBL

510(k)	Device	Applicant	Decision
K250423	mb-FIX Cranial Stabilization SystemsHBL · Traditional	Medical Bees GmbH	11/06/2025SE
K241883	DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…HBL · Special	Pro Med Instruments GmbH	07/26/2024SE
K240319	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)HBL · Traditional	Pro Med Instruments GmbH	04/24/2024SE
K203505	DORO QR3 Headrest System (Aluminum)HBL · Traditional	Pro Med Instruments GmbH	03/29/2021SE
K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…HBL · Traditional	Pro Med Instruments GmbH	06/02/2020SE
K191740	DORO LUCENT® iXI and iMRI Headrest SystemHBL · Traditional	Pro Med Instruments GmbH	02/21/2020SE
K191701	Arcus Head Fixation FrameHBL · Traditional	Mri Interventions, Inc.	11/15/2019SE
K191979	DORO QR3 XTom Headholder SystemHBL · Traditional	Pro Med Instruments GmbH	10/22/2019SE
K163322	TZ SKULL PIN AdultHBL · Traditional	Tz Medical, Inc.	02/23/2017SE
K142238	MAYFIELD Skull ClampHBL · Traditional	Integra LifeSciences Corporation	11/24/2014SE

More from Integra LifeSciences Corporation

510(k)	Device	Decision
K901372	Laminectomy RongeurHAE · Traditional	06/28/1990SE

Questions and answers

When was Mainz Head Fixation by Perneczky cleared by the FDA?

Mainz Head Fixation by Perneczky (K901393) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 162 days after the submission was received.

What is the product code of K901393?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.