HBL · Holder, Head, Neurosurgical (Skull Clamp)
Neurology · 21 CFR 882.4460 · Class 2
Overview
| Product Code | HBL |
|---|---|
| Device Name | Holder, Head, Neurosurgical (Skull Clamp) |
| Regulation | 21 CFR 882.4460 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | Nov 6, 2025 | SESE |
| 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 | Jul 26, 2024 | SESE |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Pro Med Instruments GmbH | Apr 24, 2024 | SESE |
| K203505 | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | Mar 29, 2021 | SESE |
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) | Pro Med Instruments GmbH | Jun 2, 2020 | SESE |
| K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | Feb 21, 2020 | SESE |
| K191701 | Arcus Head Fixation Frame | Mri Interventions, Inc. | Nov 15, 2019 | SESE |
| K191979 | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | Oct 22, 2019 | SESE |
| K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | Feb 23, 2017 | SESE |
| K142238 | MAYFIELD Skull Clamp | Integra LifeSciences Corporation | Nov 24, 2014 | SESE |
| K141950 | HFD100 ROCKER ARM ACCESSORY | Imris, Inc. | Sep 4, 2014 | SESE |
| K122225 | STERILE RADIOLUCENT SKULL PINS | Brainlab AG | Apr 26, 2013 | SESE |
| K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP | Integra LifeSciences Corporation | Apr 23, 2013 | SESE |
| K120633 | MAYFIELD SKULL CLAMP | Integra LifeSciences Corporation | May 24, 2012 | SESE |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Imris, Inc. | Mar 23, 2012 | SESE |
| K103493 | HEAD FIATION DEVICE (HFD 100) | Imris, Inc. | Mar 11, 2011 | SESE |
| K083803 | FIXIT HEADREST CLAMP SYSTEM | Medicon EG | Mar 10, 2010 | SESE |
| K091439 | HEAD FIXATION ARC AND TABLE BASE | Surgivision, Inc. | Aug 25, 2009 | SESE |
| K090695 | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 | Dinkler Surgical Devices, Inc. | Apr 23, 2009 | SESE |
| K090506 | 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
