Product code HBL

Device name: Holder, Head, Neurosurgical (Skull Clamp)
Medical specialty: Neurology
Device class: 2
Regulation number: 882.4460
Review panel: NE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250423	mb-FIX Cranial Stabilization Systems	Medical Bees GmbH	2025-11-06
K241883	DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO St...	Pro Med Instruments GmbH	2024-07-26
K240319	DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)	Pro Med Instruments GmbH	2024-04-24
K203505	DORO QR3 Headrest System (Aluminum)	Pro Med Instruments GmbH	2021-03-29
K193438	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)	Pro Med Instruments GmbH	2020-06-02
K191740	DORO LUCENT® iXI and iMRI Headrest System	Pro Med Instruments GmbH	2020-02-21
K191701	Arcus Head Fixation Frame	Mri Interventions, Inc.	2019-11-15
K191979	DORO QR3 XTom Headholder System	Pro Med Instruments GmbH	2019-10-22
K163322	TZ SKULL PIN Adult	Tz Medical, Inc.	2017-02-23
K142238	MAYFIELD Skull Clamp	Integra LifeSciences Corporation	2014-11-24
K141950	HFD100 ROCKER ARM ACCESSORY	Imris, Inc.	2014-09-04
K122225	STERILE RADIOLUCENT SKULL PINS	Brainlab AG	2013-04-26
K130389	MAYFIELD INFINITY XR2 SKULL CLAMP	Integra LifeSciences Corporation	2013-04-23
K120633	MAYFIELD SKULL CLAMP	Integra LifeSciences Corporation	2012-05-24
K113748	IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)	Imris, Inc.	2012-03-23
K103493	HEAD FIATION DEVICE (HFD 100)	Imris, Inc.	2011-03-11
K083803	FIXIT HEADREST CLAMP SYSTEM	Medicon EG	2010-03-10
K091439	HEAD FIXATION ARC AND TABLE BASE	Surgivision, Inc.	2009-08-25
K090695	DINKLER SURGICAL SKULL CLAMP, MODEL 0308	Dinkler Surgical Devices, Inc.	2009-04-23
K090506	MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114	Integra LifeSciences Corporation	2009-04-20
K081401	MAYFIELD MR/X-RAY SKULL CLAMP	Integra Lifesciences Corp.	2008-10-08
K073163	LIMITED ARTIFACT SKULL PIN, MODEL 0107	Dinkler Surgical Devices, Inc.	2008-02-28
K072208	MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS	Integra LifeSciences Corporation	2007-09-07
K071458	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	Integra LifeSciences Corporation	2007-06-13
K063494	DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS	Pro-Med Instruments GmbH	2007-05-21
K053045	MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020	Integra LifeSciences Corporation	2005-11-21
K051440	MAYFIELD INFINITY SKULL CLAMP	Integra Lifesciences Corp.	2005-09-20
K050319	MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104	Integra Lifesciences Corp.	2005-03-31
K032331	DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)	Pro-Med Instruments GmbH	2003-11-20
K031885	NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX	Image-Guided Neurologics, Inc.	2003-08-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10381780253464	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253631	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253624	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253617	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253600	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253594	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253587	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253570	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253563	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253556	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253549	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253532	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253525	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253518	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253471	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025757	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253457	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253402	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253396	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253389	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253372	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253365	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253358	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253341	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780253334	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025818	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025795	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025788	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025771	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26
10381780025764	MAYFIELD®	INTEGRA LIFESCIENCES CORPORATION	2016-07-26

Product code HBL

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