HBB — Motor, Drill, Pneumatic Class II

FDA Device Classification

Classification Details

Product Code
HBB
Device Class
Class II
Regulation Number
882.4370
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253772adeor medicalVelocity Alpha MR High Speed Surgical Drill SystemMarch 6, 2026
K172907aesculapELAN 4 Air Motor SystemNovember 9, 2018
K163182medtronic powered surgical solutionsMedtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorpoMarch 23, 2017
K150801stryker corporationStryker Maestro Air MotorsMay 22, 2015
K101168medtronic sofamor danekLEGEND POWER ADAPTER MODEL: 6475000August 24, 2010
K093361synthes (usa)SYNTHES AIR PEN DRIVE (APD) SYSTEMApril 14, 2010
K090112medtronic powered surgical solutionsMIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PCMarch 26, 2009
K061297anspach effortANSPACH IMRI SAFE SURGICAL DRILL SYSTEMJanuary 26, 2007
K061725stryker instrumentsSTRYKER ARIA PNEUMATIC SYSTEMOctober 26, 2006
K042974medicon egMEDICON VIPAIR HIGH SPEED SYSTEMJanuary 13, 2005
K041754strykerSTRYKER MAESTRO SYSTEMSeptember 7, 2004
K040186anspach effortANSPACH MRI SAFE SURGICAL DRILL SYSTEMApril 15, 2004
K023066sodemsystemsDRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)November 25, 2002
K020069medtronic midas rexMEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OMarch 18, 2002
K013091von zeppelinZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEMJanuary 25, 2002
K000195image-guided neurologicsCRANIAL DRILLApril 20, 2000
K993851sodemsystemsSODEM PERFORATOR DRIVEDecember 27, 1999
K994175sodemsystemsMODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USEDecember 21, 1999
K991625komet medicalKOMET XK-95 PERFORATOR MOTOR (MI-102)July 30, 1999
K983092mednextTRITON HUDSON CHUCK ATTACHMENTNovember 6, 1998