HBG — Drills, Burrs, Trephines & Accessories (Manual) Class II
FDA Device Classification
Classification Details
- Product Code
- HBG
- Device Class
- Class II
- Regulation Number
- 882.4300
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252696 | phasor health | LEGACY | November 21, 2025 |
| K153587 | synthes (usa) products | Taps for Resorbable Screws | January 18, 2017 |
| K162884 | spineguard | SpineGuard DSG Zavation Screw System | January 12, 2017 |
| K160129 | mri interventions | MRII Cranial Drill and Accessories | March 26, 2016 |
| K151536 | mri interventions | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | July 8, 2015 |
| K122456 | mri interventions | MRII CRAINIAL DRILL | March 22, 2013 |
| K022712 | medical design | HAND DRILL, MODEL 11-9901-7 | November 12, 2002 |
| K022370 | medtronic xomed | FRAMELOCK; FRAMELOCK ACCESSORIES | October 18, 2002 |
| K961113 | clinical neuro systems | CNS INTERCHANGEABLE BIT CRANIAL DRILL | June 5, 1996 |
| K932402 | neurodynamics | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | August 5, 1993 |
| K915546 | pudenz-schulte medical research | PS MEDICAL VENTRICULOSTOMY KIT | December 30, 1991 |
| K904283 | pudenz-schulte medical research | PS MEDICAL CRANIAL HAND DRILL | October 3, 1990 |
| K902818 | ruggles | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | September 20, 1990 |
| K892531 | zinnanti surgical instruments | NEUROSURGICAL DRILLS: STILLE, HUDSON | May 5, 1989 |
| K875018 | neurodynamics | GHAJAR GUIDE TWIST DRILL | January 28, 1988 |
| K874952 | solway | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | December 30, 1987 |
| K862160 | camino laboratories | CAMINO HAND DRILL - MODEL 030 | July 18, 1986 |