Drills, Burrs, Trephines & Accessories (Simple, Powered)

FDA product code HBE · 60 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.4310
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1987-12-17 – 2026-03-26

HBE 2026-03-26

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

Applicant Surgify Medical OY

K number K253627

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HBE 2025-11-06

Hubly Drill (H100)

Applicant Hubly, Inc.

K number K250815

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HBE 2025-10-31

GREEN

Applicant Phasor Health, LLC

K number K252060

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HBE 2025-09-19

UniBur

Applicant Nakanishi, Inc.

K number K252662

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HBE 2025-06-04

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)

Applicant Surgify Medical OY

K number K251433

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HBE 2025-03-13

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

Applicant Surgify Medical OY

K number K250380

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HBE 2025-03-11

iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R

Applicant Stryker Instruments

K number K250374

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HBE 2023-11-29

Surgify Halo

Applicant Surgify Medical OY

K number K232684

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HBE 2023-05-04

Hubly Electric Drill (H100)

Applicant Hubly, Inc.

K number K230619

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HBE 2022-11-15

2.1 x 255mm Drill, 22mm Stop

Applicant Biomet Microfixation

K number K223199

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HBE 2022-08-23

2.1 x 255mm Drill, 22mm Stop

Applicant Biomet Micofixation

K number K213072

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HBE 2021-12-23

Twist Drills

Applicant Biomet Microfixation

K number K213208

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HBE 2021-11-23

Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

Applicant Medtronic Powered Surgical Solutions

K number K213454

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HBE 2021-10-22

P300 Attachment

Applicant Nakanishi, Inc.

K number K202120

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HBE 2021-08-24

ELAN 4 Electro Motor System

Applicant Aesculap, Inc.

K number K203739

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HBE 2021-06-30

Stryker iBur hubs and cutting accessories

Applicant Stryker Corporation

K number K210377

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HBE 2021-04-11

Velocity Alpha Highspeed Surgical Drill System

Applicant Adeor Medical AG

K number K191479

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HBE 2019-08-09

ELAN 4 Tools

Applicant Aesculap, Inc.

K number K183203

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HBE 2019-07-19

Anspach Helix Dissection Tools

Applicant The Anspach Effort, Inc.

K number K183545

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HBE 2019-06-18

Stryker MIS and Footed Attachments

Applicant Stryker Corporation

K number K191049

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HBE 2019-06-14

Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

Applicant Stryker

K number K190172

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HBE 2019-01-19

ELAN 4 Tools

Applicant Aesculap, Inc.

K number K182527

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HBE 2018-10-17

ELAN 4 Electro Motor System Tools

Applicant Aesculap, Inc.

K number K172709

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HBE 2018-10-04

POWEREASE System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K182436

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HBE 2017-09-07

Cranial Drill Bits and Accessories

Applicant Ad-Tech Medical Instrument Corporation

K number K170442

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HBE 2017-05-19

OsteoMed PINNACLE Driver

Applicant Osteomed

K number K162542

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HBE 2016-12-01

Phasor Drill

Applicant Biotex, Inc.

K number K161704

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HBE 2016-03-16

DReal

Applicant Carevature Medical, Ltd.

K number K153519

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HBE 2013-01-11

POWEREASE SYSTEM

Applicant Medtronic Sofamor Danek USA, Inc.

K number K123270

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HBE 2012-08-27

TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

Applicant Medtronic Surgical Technologies

K number K121264

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HBE 2011-12-16

ANSPACH DISSECTION TOOLS

Applicant The Anspach Effort, Inc.

K number K113476

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HBE 2011-10-26

IPC POWEREASE SYSTEM

Applicant Medtronic Xomed, Inc.

K number K111520

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HBE 2008-10-17

ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]

Applicant Medtronic Xomed, Inc.

K number K081475

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HBE 2008-04-30

EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

Applicant The Anspach Effort, Inc.

K number K080802

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HBE 2007-09-18

MIDAS REX CURVED BUR

Applicant Medtronic Powered Surgical Solutions

K number K072315

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HBE 2007-04-27

STRYKER TWIST DRILLS

Applicant Stryker Craniomaxillofacial

K number K070876

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HBE 2006-12-04

TWIST DRILL

Applicant Walter Lorenz Surgical, Inc.

K number K062842

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HBE 2005-04-07

ANSPACH COUPLER

Applicant The Anspach Effort, Inc.

K number K050628

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HBE 2004-12-17

ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM

Applicant The Anspach Effort, Inc.

K number K042783

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HBE 2004-03-15

ANSPACH ADVANCED MICRO SAW ATTACHMENTS

Applicant The Anspach Effort, Inc.

K number K040076

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HBE 2004-01-16

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Applicant Stryker Instruments

K number K032303

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HBE 2003-04-03

SMALL HIGH SPEED MOTOR DRILL SYSTEM

Applicant Brasseler USA I, L.P.

K number K030172

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HBE 2002-10-21

CRANIOCUT

Applicant Aesculap, Inc.

K number K022942

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HBE 2002-03-05

MICROAIRE 1000E SYSTEM

Applicant Microaire Surgical Instruments, Inc.

K number K014060

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HBE 2000-10-24

ANSPACH ANGLED MICRONOSE ATTACHMENT

Applicant The Anspach Effort, Inc.

K number K002903

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HBE 1999-06-03

XK-95 HIGH SPEED MOTOR DRILL SYSTEM

Applicant Komet Medical

K number K984035

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HBE 1995-05-18

75K STAIGHT DRILL

Applicant Stryker Corp.

K number K943541

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HBE 1994-05-03

MEDNEXT BUR

Applicant Mednext, Inc.

K number K935861

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HBE 1993-03-16

CLINICAL NEURO SYSTEMS CRANIAL DRILL

Applicant Clinical Neuro Systems, LLC

K number K930229

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HBE 1992-10-13

ZEPPELIN MOTOR DRILL SYSTEM

Applicant Von Zeppelin Chirurgische Instrumente GmbH

K number K922299

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HBE 1991-09-10

ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED

Applicant Acra Cut, Inc.

K number K911819

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HBE 1991-09-10

ACRA-CUT WIRE PASS DRILL

Applicant Acra Cut, Inc.

K number K911812

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HBE 1990-12-21

MICRO-AIRE MODEL NUMBER: MK-426

Applicant Micro Surgical Instruments Corp.

K number K905097

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HBE 1990-11-13

CRANIOTOME BLADE OR DRILL BIT

Applicant A. Henniss

K number K902703

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HBE 1990-09-13

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL

Applicant Micro-Aire Surgical Instruments, Inc.

K number K903664

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HBE 1990-05-07

MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES

Applicant Midas Rex Pneumatic Tools, Inc.

K number K900388

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HBE 1988-05-31

CRANIOTOME BLADE OR NEURO BLADE

Applicant Nuell Air Equipment & Hospital Supplies, Inc.

K number K881418

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HBE 1988-05-06

WIRE PASS DRILL BITS

Applicant Nuell Air Equipment & Hospital Supplies, Inc.

K number K880601

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HBE 1988-01-28

HUDSON CRANINAL BURRS

Applicant Tri-Med, Inc.

K number K875224

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HBE 1987-12-17

RAYLOR(TM) DRILL STOP

Applicant Cedar Surgical, Inc.

K number K873692

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