FDA Product Code
FDA Product Code HBL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4460
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025-11-06 | Traditional | PDF ↗ |
| 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 Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | Pro Med Instruments GmbH | 2024-07-26 | Special | PDF ↗ |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH | 2024-04-24 | Traditional | PDF ↗ |
| K203505 | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | 2021-03-29 | Traditional | PDF ↗ |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH | 2020-06-02 | Traditional | PDF ↗ |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | 2020-02-21 | Traditional | PDF ↗ |
| K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | 2019-11-15 | Traditional | PDF ↗ |
| K191979 | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | 2019-10-22 | Traditional | PDF ↗ |
| K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | 2017-02-23 | Traditional | PDF ↗ |
| K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | 2014-11-24 | Traditional | PDF ↗ |
| K141950 | HFD100 ROCKER ARM ACCESSORY | Imris, Inc. | 2014-09-04 | Special | PDF ↗ |
| K122225 | STERILE RADIOLUCENT SKULL PINS | Brainlab AG | 2013-04-26 | Traditional | PDF ↗ |
| K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | Integra LifeSciences Corporation | 2013-04-23 | Traditional | PDF ↗ |
| K120633 | MAYFIELD SKULL CLAMP | Integra LifeSciences Corporation | 2012-05-24 | Traditional | PDF ↗ |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Imris, Inc. | 2012-03-23 | Traditional | PDF ↗ |
| K103493 | HEAD FIATION DEVICE (HFD 100) | Imris, Inc. | 2011-03-11 | Traditional | PDF ↗ |
| K083803 | FIXIT HEADREST CLAMP SYSTEM | Medicon EG | 2010-03-10 | Traditional | PDF ↗ |
| K091439 | HEAD FIXATION ARC AND TABLE BASE | Surgivision, Inc. | 2009-08-25 | Traditional | PDF ↗ |
| K090695 | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | Dinkler Surgical Devices, Inc. | 2009-04-23 | Traditional | PDF ↗ |
| K090506 | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | Integra LifeSciences Corporation | 2009-04-20 | Traditional | PDF ↗ |
| K081401 | MAYFIELD MR/X-RAY SKULL CLAMP | Integra Lifesciences Corp. | 2008-10-08 | Special | PDF ↗ |
| K073163 | LIMITED ARTIFACT SKULL PIN, MODEL 0107 | Dinkler Surgical Devices, Inc. | 2008-02-28 | Traditional | PDF ↗ |
| K072208 | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS | Integra LifeSciences Corporation | 2007-09-07 | Special | PDF ↗ |
| K071458 | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS | Integra LifeSciences Corporation | 2007-06-13 | Special | PDF ↗ |
| K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS | Pro-Med Instruments GmbH | 2007-05-21 | Traditional | PDF ↗ |
| K053045 | MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | Integra LifeSciences Corporation | 2005-11-21 | Special | PDF ↗ |
| K051440 | MAYFIELD INFINITY SKULL CLAMP | Integra Lifesciences Corp. | 2005-09-20 | Traditional | PDF ↗ |
| K050319 | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 | Integra Lifesciences Corp. | 2005-03-31 | Traditional | PDF ↗ |
| K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) | Pro-Med Instruments GmbH | 2003-11-20 | Traditional | PDF ↗ |
| K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | Image-Guided Neurologics, Inc. | 2003-08-21 | Traditional | PDF ↗ |
| K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | Ohio Medical Instrument Co., Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | Vascular Technology Incorporated | 2000-11-06 | Traditional | PDF ↗ |
| K002276 | PSI SKULL CLAMP | V. Mueller Neuro/Spine | 2000-08-29 | Traditional | PDF ↗ |
| K001808 | DORO HEADREST SYSTEM | Pro-Med Instruments GmbH | 2000-08-04 | Traditional | PDF ↗ |
| K955012 | MIZUHO RADIOLUCENT HEAD FRAME | Mizuho America, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP | Ohio Medical Instrument Co., Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN | Ohio Medical Instrument Co., Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K934289 | MAYFIELD RADIOLUCENT SKULL CLAMP | Ohio Medical Instrument Co., Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K932807 | MAYFIELD* A-2000 SKULL CLAMP | Ohio Medical Instrument Co., Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN | Ohio Medical Instrument Co., Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN | Ohio Medical Instrument Co., Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K912005 | CODMAN SKULL PINS (ADULT & CHILD), REUSABLE | Codman & Shurtleff, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K911723 | CODMAN DISPOSABLE SKULL PINS | Codman & Shurtleff, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K913170 | CODMAN SKULL CLAMP | Codman & Shurtleff, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K911772 | GARDNER PINS (ADULT & CHILD) | Codman & Shurtleff, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K912011 | CODMAN SKULL CLAMP | Codman & Shurtleff, Inc. | 1991-07-31 | Traditional | PDF ↗ |
| K901393 | MAINZ HEAD FIXATION BY PERNECZKY | Zeppelin GmbH | 1990-09-04 | Traditional | PDF ↗ |
| K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM | Medical Equipment Development Co., Inc. | 1989-08-29 | Traditional | PDF ↗ |
| K874298 | MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME | Engineered Orthopedic Technologies, Inc. | 1988-02-04 | Traditional | PDF ↗ |
| K821772 | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR | Downs Surgical , Ltd. | 1982-09-28 | Traditional | PDF ↗ |
Product code HBL · Class II · Neurology. Data: openFDA.