Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4300](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4300) → HBG — Drills, Burrs, Trephines & Accessories (Manual)

# HBG · Drills, Burrs, Trephines & Accessories (Manual)

_Neurology · 21 CFR 882.4300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG

## Overview

- **Product Code:** HBG
- **Device Name:** Drills, Burrs, Trephines & Accessories (Manual)
- **Regulation:** [21 CFR 882.4300](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4300)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (17 of 17)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252696](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K252696.md) | LEGACY | Phasor Health, LLC | Nov 21, 2025 | SESE |
| [K153587](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K153587.md) | Taps for Resorbable Screws | Synthes (USA) Products, LLC | Jan 18, 2017 | SESE |
| [K162884](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K162884.md) | SpineGuard DSG Zavation Screw System | Spineguard S.A. | Jan 12, 2017 | SESE |
| [K160129](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K160129.md) | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | Mar 26, 2016 | SESE |
| [K151536](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K151536.md) | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | Jul 8, 2015 | SESE |
| [K122456](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K122456.md) | MRII CRAINIAL DRILL | Mri Interventions, Inc. | Mar 22, 2013 | SESE |
| [K022712](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K022712.md) | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | Nov 12, 2002 | SESE |
| [K022370](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K022370.md) | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | Oct 18, 2002 | SESE |
| [K961113](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K961113.md) | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | Jun 5, 1996 | SESE |
| [K932402](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K932402.md) | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | Aug 5, 1993 | SESE |
| [K915546](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K915546.md) | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | Dec 30, 1991 | SESE |
| [K904283](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K904283.md) | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | Oct 3, 1990 | SESE |
| [K902818](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K902818.md) | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | Sep 20, 1990 | SESE |
| [K892531](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K892531.md) | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | May 5, 1989 | SESE |
| [K875018](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K875018.md) | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | Jan 28, 1988 | SESE |
| [K874952](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K874952.md) | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | Dec 30, 1987 | SESE |
| [K862160](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG/K862160.md) | CAMINO HAND DRILL - MODEL 030 | Camino Laboratories, Inc. | Jul 18, 1986 | SESE |

## Top Applicants

- Mri Interventions, Inc. — 3 clearances
- Neurodynamics, Inc. — 2 clearances
- Pudenz-Schulte Medical Research Corp. — 2 clearances
- Camino Laboratories, Inc. — 1 clearance
- Clinical Neuro Systems, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBG)

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