Head Fiation Device (HFD 100)

Q: What is the product code of K103493?

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) K103493 · Imris, Inc.

Substantially Equivalent

510(k) numberK103493

Submission

Device name: Head Fiation Device (HFD 100)
Applicant: Imris, Inc.
Rockville, MD, US
Received: November 29, 2010
Decision date: March 11, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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
K143420	SYMBIS Surgical SystemHAW · Traditional	10/30/2015SE
K141950	HFD100 Rocker Arm AccessoryHBL · Special	09/04/2014SE
K133692	Imri 1.5T and Imri 3T SLNH · Traditional	02/10/2014SE
K130224	IctJAK · Traditional	07/18/2013SE
K123091	Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TMOS · Traditional	12/27/2012SE
K121997	Imris Oncology PackageLNH · Traditional	08/10/2012SE
K113748	Imris Mr/X-Ray Head Fixation Device (HFD)HBL · Traditional	03/23/2012SE
K103506	1.5T Head Coil (HC150), 3T Head Coil (HC300)MOS · Traditional	02/02/2011SE
K101813	Imrx System V1 and Imrisnv/ImriscardioLNH · Traditional	10/05/2010SE
K091166	ImrxLNH · Traditional	09/02/2009SE

Questions and answers

When was Head Fiation Device (HFD 100) cleared by the FDA?

Head Fiation Device (HFD 100) (K103493) received a 510(k) decision of Substantially Equivalent on March 11, 2011, 102 days after the submission was received.

What is the product code of K103493?

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