FDA 510(k) Applications for Medical Device Product Code "HBL"
(Holder, Head, Neurosurgical (Skull Clamp))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K122225 | BRAINLAB AG | STERILE RADIOLUCENT SKULL PINS | 04/26/2013 |
| K090695 | DINKLER SURGICAL DEVICES, INC. | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | 04/23/2009 |
| K073163 | DINKLER SURGICAL DEVICES, INC. | LIMITED ARTIFACT SKULL PIN, MODEL 0107 | 02/28/2008 |
| K031885 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | 08/21/2003 |
| K103493 | IMRIS, INC. | HEAD FIATION DEVICE (HFD 100) | 03/11/2011 |
| K141950 | IMRIS, INC. | HFD100 ROCKER ARM ACCESSORY | 09/04/2014 |
| K113748 | IMRIS, INC. | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | 03/23/2012 |
| K051440 | INTEGRA LIFESCIENCES CORP. | MAYFIELD INFINITY SKULL CLAMP | 09/20/2005 |
| K050319 | INTEGRA LIFESCIENCES CORP. | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 | 03/31/2005 |
| K081401 | INTEGRA LIFESCIENCES CORP. | MAYFIELD MR/X-RAY SKULL CLAMP | 10/08/2008 |
| K072208 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS | 09/07/2007 |
| K130389 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD INFINITY XR2 SKULL CLAMP | 04/23/2013 |
| K090506 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | 04/20/2009 |
| K071458 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS | 06/13/2007 |
| K120633 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD SKULL CLAMP | 05/24/2012 |
| K142238 | INTEGRA LIFESCIENCES CORPORATION | MAYFIELD Skull Clamp | 11/24/2014 |
| K053045 | INTEGRA LIFESCIENCES CORPORATION | MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | 11/21/2005 |
| K083803 | MEDICON, E.G. | FIXIT HEADREST CLAMP SYSTEM | 03/10/2010 |
| K955012 | MIZUHO AMERICA, INC. | MIZUHO RADIOLUCENT HEAD FRAME | 09/12/1996 |
| K191701 | MRI Interventions, Inc. | Arcus Head Fixation Frame | 11/15/2019 |
| K953124 | OHIO MEDICAL INSTRUMENT CO., INC. | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP | 02/09/1996 |
| K021604 | OHIO MEDICAL INSTRUMENT CO., INC. | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 | 07/29/2002 |
| K191740 | Pro Med Instruments GmbH | DORO LUCENT« iXI and iMRI Headrest System | 02/21/2020 |
| K203505 | pro med instruments GmbH | DORO QR3 Headrest System (Aluminum) | 03/29/2021 |
| K191979 | Pro Med Instruments GmbH | DORO QR3 XTom Headholder System | 10/22/2019 |
| K193438 | Pro Med Instruments GmbH | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | 06/02/2020 |
| K001808 | PRO-MED INSTRUMENTS GMBH | DORO HEADREST SYSTEM | 08/04/2000 |
| K063494 | PRO-MED INSTRUMENTS GMBH | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS | 05/21/2007 |
| K032331 | PRO-MED INSTRUMENTS GMBH | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) | 11/20/2003 |
| K091439 | SURGIVISION, INC. | HEAD FIXATION ARC AND TABLE BASE | 08/25/2009 |
| K163322 | TZ MEDICAL INC | TZ SKULL PIN Adult | 02/23/2017 |
| K002276 | V. MUELLER NEURO/SPINE | PSI SKULL CLAMP | 08/29/2000 |
| K002990 | VASCULAR TECHNOLOGY INCORPORATED | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | 11/06/2000 |
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