Atlas FDA

HBL

50 FDA 510(k) clearances · Product code

104 daysmedian time to decision
265 days90th percentile
50clearances measured

FDA profile

Official device name
Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 512 · 2022: 268 · 2023: 265 · 2024: 197 · 2025: 276 · 2026: 106
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
mb-FIX Cranial Stabilization Systems (K250423)Medical Bees GmbH2025-11-06
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 Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) (K241883)Pro Med Instruments GmbH2024-07-26
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) (K240319)Pro Med Instruments GmbH2024-04-24
DORO QR3 Headrest System (Aluminum) (K203505)Pro Med Instruments GmbH2021-03-29
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (K193438)Pro Med Instruments GmbH2020-06-02
DORO LUCENT® iXI and iMRI Headrest System (K191740)Pro Med Instruments GmbH2020-02-21
Arcus Head Fixation Frame (K191701)Mri Interventions, Inc.2019-11-15
DORO QR3 XTom Headholder System (K191979)Pro Med Instruments GmbH2019-10-22
TZ SKULL PIN Adult (K163322)Tz Medical, Inc.2017-02-23
MAYFIELD Skull Clamp (K142238)Integra LifeSciences Corporation2014-11-24
HFD100 ROCKER ARM ACCESSORY (K141950)Imris, Inc.2014-09-04
STERILE RADIOLUCENT SKULL PINS (K122225)Brainlab AG2013-04-26
MAYFIELD INFINITY XR2 SKULL CLAMP (K130389)Integra LifeSciences Corporation2013-04-23
MAYFIELD SKULL CLAMP (K120633)Integra LifeSciences Corporation2012-05-24
IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) (K113748)Imris, Inc.2012-03-23
HEAD FIATION DEVICE (HFD 100) (K103493)Imris, Inc.2011-03-11
FIXIT HEADREST CLAMP SYSTEM (K083803)Medicon EG2010-03-10
HEAD FIXATION ARC AND TABLE BASE (K091439)Surgivision, Inc.2009-08-25
DINKLER SURGICAL SKULL CLAMP, MODEL 0308 (K090695)Dinkler Surgical Devices, Inc.2009-04-23
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 (K090506)Integra LifeSciences Corporation2009-04-20
MAYFIELD MR/X-RAY SKULL CLAMP (K081401)Integra Lifesciences Corp.2008-10-08
LIMITED ARTIFACT SKULL PIN, MODEL 0107 (K073163)Dinkler Surgical Devices, Inc.2008-02-28
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS (K072208)Integra LifeSciences Corporation2007-09-07
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS (K071458)Integra LifeSciences Corporation2007-06-13
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS (K063494)Pro-Med Instruments GmbH2007-05-21
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K053045)Integra LifeSciences Corporation2005-11-21
MAYFIELD INFINITY SKULL CLAMP (K051440)Integra Lifesciences Corp.2005-09-20
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 (K050319)Integra Lifesciences Corp.2005-03-31
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) (K032331)Pro-Med Instruments GmbH2003-11-20
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (K031885)Image-Guided Neurologics, Inc.2003-08-21
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K021604)Ohio Medical Instrument Co., Inc.2002-07-29
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 (K002990)Vascular Technology Incorporated2000-11-06
PSI SKULL CLAMP (K002276)V. Mueller Neuro/Spine2000-08-29
DORO HEADREST SYSTEM (K001808)Pro-Med Instruments GmbH2000-08-04
MIZUHO RADIOLUCENT HEAD FRAME (K955012)Mizuho America, Inc.1996-09-12
MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (K953124)Ohio Medical Instrument Co., Inc.1996-02-09
MAYFIELD CHILD DISPOSABLE SKULL PIN (K941558)Ohio Medical Instrument Co., Inc.1995-12-06
MAYFIELD RADIOLUCENT SKULL CLAMP (K934289)Ohio Medical Instrument Co., Inc.1994-01-07
MAYFIELD ADULT DISPOSABLE SKULL PIN (K932860)Ohio Medical Instrument Co., Inc.1993-09-28
MAYFIELD* A-2000 SKULL CLAMP (K932807)Ohio Medical Instrument Co., Inc.1993-09-28
MAYFIELD ADULT DISPOSABLE SKULL PIN (K923789)Ohio Medical Instrument Co., Inc.1993-02-12
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE (K912005)Codman & Shurtleff, Inc.1991-09-19
CODMAN DISPOSABLE SKULL PINS (K911723)Codman & Shurtleff, Inc.1991-09-10
CODMAN SKULL CLAMP (K913170)Codman & Shurtleff, Inc.1991-09-06
GARDNER PINS (ADULT & CHILD) (K911772)Codman & Shurtleff, Inc.1991-08-26
CODMAN SKULL CLAMP (K912011)Codman & Shurtleff, Inc.1991-07-31
MAINZ HEAD FIXATION BY PERNECZKY (K901393)Zeppelin GmbH1990-09-04
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM (K893911)Medical Equipment Development Co., Inc.1989-08-29
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME (K874298)Engineered Orthopedic Technologies, Inc.1988-02-04
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR (K821772)Downs Surgical , Ltd.1982-09-28

Track HBL automatically

Every clearance here is in the API, with alerts when new ones post.