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HBL — Holder, Head, Neurosurgical (Skull Clamp) Class II

FDA Device Classification

Classification Details

Product Code
HBL
Device Class
Class II
Regulation Number
882.4460
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250423medical beesmb-FIX Cranial Stabilization SystemsNovember 6, 2025
K241883pro med instrumentsDORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DJuly 26, 2024
K240319pro med instrumentsDORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.April 24, 2024
K203505pro med instrumentsDORO QR3 Headrest System (Aluminum)March 29, 2021
K193438pro med instrumentsDORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable SJune 2, 2020
K191740pro med instrumentsDORO LUCENT® iXI and iMRI Headrest SystemFebruary 21, 2020
K191701mri interventionsArcus Head Fixation FrameNovember 15, 2019
K191979pro med instrumentsDORO QR3 XTom Headholder SystemOctober 22, 2019
K163322tz medicalTZ SKULL PIN AdultFebruary 23, 2017
K142238integra lifesciences corporationMAYFIELD Skull ClampNovember 24, 2014
K141950imrisHFD100 ROCKER ARM ACCESSORYSeptember 4, 2014
K122225brainlabSTERILE RADIOLUCENT SKULL PINSApril 26, 2013
K130389integra lifesciences corporationMAYFIELD INFINITY XR2 SKULL CLAMPApril 23, 2013
K120633integra lifesciences corporationMAYFIELD SKULL CLAMPMay 24, 2012
K113748imrisIMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)March 23, 2012
K103493imrisHEAD FIATION DEVICE (HFD 100)March 11, 2011
K083803medicon egFIXIT HEADREST CLAMP SYSTEMMarch 10, 2010
K091439surgivisionHEAD FIXATION ARC AND TABLE BASEAugust 25, 2009
K090695dinkler surgical devicesDINKLER SURGICAL SKULL CLAMP, MODEL 0308April 23, 2009
K090506integra lifesciences corporationMAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114April 20, 2009