Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4460](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4460) → HBL — Holder, Head, Neurosurgical (Skull Clamp) # HBL · Holder, Head, Neurosurgical (Skull Clamp) _Neurology · 21 CFR 882.4460 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL ## Overview - **Product Code:** HBL - **Device Name:** Holder, Head, Neurosurgical (Skull Clamp) - **Regulation:** [21 CFR 882.4460](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4460) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 50) Showing 20 most recent of 50 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250423](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K250423.md) | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | Nov 6, 2025 | SESE | | [K241883](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K241883.md) | 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 | Jul 26, 2024 | SESE | | [K240319](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K240319.md) | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH | Apr 24, 2024 | SESE | | [K203505](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K203505.md) | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | Mar 29, 2021 | SESE | | [K193438](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K193438.md) | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH | Jun 2, 2020 | SESE | | [K191740](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K191740.md) | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | Feb 21, 2020 | SESE | | [K191701](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K191701.md) | Arcus Head Fixation Frame | Mri Interventions, Inc. | Nov 15, 2019 | SESE | | [K191979](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K191979.md) | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | Oct 22, 2019 | SESE | | [K163322](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K163322.md) | TZ SKULL PIN Adult | Tz Medical, Inc. | Feb 23, 2017 | SESE | | [K142238](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K142238.md) | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | Nov 24, 2014 | SESE | | [K141950](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K141950.md) | HFD100 ROCKER ARM ACCESSORY | Imris, Inc. | Sep 4, 2014 | SESE | | [K122225](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K122225.md) | STERILE RADIOLUCENT SKULL PINS | Brainlab AG | Apr 26, 2013 | SESE | | [K130389](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K130389.md) | MAYFIELD INFINITY XR2 SKULL CLAMP | Integra LifeSciences Corporation | Apr 23, 2013 | SESE | | [K120633](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K120633.md) | MAYFIELD SKULL CLAMP | Integra LifeSciences Corporation | May 24, 2012 | SESE | | [K113748](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K113748.md) | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Imris, Inc. | Mar 23, 2012 | SESE | | [K103493](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K103493.md) | HEAD FIATION DEVICE (HFD 100) | Imris, Inc. | Mar 11, 2011 | SESE | | [K083803](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K083803.md) | FIXIT HEADREST CLAMP SYSTEM | Medicon EG | Mar 10, 2010 | SESE | | [K091439](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K091439.md) | HEAD FIXATION ARC AND TABLE BASE | Surgivision, Inc. | Aug 25, 2009 | SESE | | [K090695](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K090695.md) | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | Dinkler Surgical Devices, Inc. | Apr 23, 2009 | SESE | | [K090506](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K090506.md) | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 | Integra LifeSciences Corporation | Apr 20, 2009 | SESE | ## Top Applicants - Integra LifeSciences Corporation — 7 clearances - Ohio Medical Instrument Co., Inc. — 7 clearances - Pro Med Instruments GmbH — 6 clearances - Codman & Shurtleff, Inc. — 5 clearances - Imris, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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