Atlas FDA

HBG

17 FDA 510(k) clearances · Product code

77 daysmedian time to decision
221 days90th percentile
17clearances measured

FDA profile

Official device name
Drills, Burrs, Trephines & Accessories (Manual)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4300
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 1 · 2000: 1 · 2002: 1 · 2003: 10 · 2004: 2 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LEGACY (K252696)Phasor Health, LLC2025-11-21
Taps for Resorbable Screws (K153587)Synthes (USA) Products, LLC2017-01-18
SpineGuard DSG Zavation Screw System (K162884)Spineguard S.A.2017-01-12
MRII Cranial Drill and Accessories (K160129)Mri Interventions, Inc.2016-03-26
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536)Mri Interventions, Inc.2015-07-08
MRII CRAINIAL DRILL (K122456)Mri Interventions, Inc.2013-03-22
HAND DRILL, MODEL 11-9901-7 (K022712)Medical Design, LLC2002-11-12
FRAMELOCK; FRAMELOCK ACCESSORIES (K022370)Medtronic Xomed, Inc.2002-10-18
CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113)Clinical Neuro Systems, LLC1996-06-05
MODIFICATION TO GHAJAR GUIDE TWIST DRILL (K932402)Neurodynamics, Inc.1993-08-05
PS MEDICAL VENTRICULOSTOMY KIT (K915546)Pudenz-Schulte Medical Research Corp.1991-12-30
PS MEDICAL CRANIAL HAND DRILL (K904283)Pudenz-Schulte Medical Research Corp.1990-10-03
MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (K902818)Ruggles Corp.1990-09-20
NEUROSURGICAL DRILLS: STILLE, HUDSON (K892531)Zinnanti Surgical Instruments, Inc.1989-05-05
GHAJAR GUIDE TWIST DRILL (K875018)Neurodynamics, Inc.1988-01-28
MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES (K874952)Solway, Inc.1987-12-30
CAMINO HAND DRILL - MODEL 030 (K862160)Camino Laboratories, Inc.1986-07-18

Track HBG automatically

Every clearance here is in the API, with alerts when new ones post.