BEUDAMED
    Product Code: HBE FDA class 2 21 CFR 882.4310

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

    Neurology

    Drills, Burrs, Trephines and Accessories (Simple, Powered) are powered neurosurgical cutting tools used to perforate and remove sections of the skull during craniotomy, craniectomy, or access procedures, with simpler mechanical configurations suited to straightforward bone cutting tasks. They are classified as Class 2 devices (moderate risk), requiring 510(k) premarket notification. The product code is HBE under regulation 21 CFR 882.4310 in the Neurology specialty. These devices are eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    61
    FEI Numbers
    136
    Registration Numbers
    136
    Unique Applicants
    46
    Years Active
    37

    Basic Information

    Product Code
    HBE
    Device Class
    FDA class 2
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 61 510(k) clearances via K numbers.

    K Number Device Name
    K251433 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)
    K250380 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)
    K250374 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
    K232684 Surgify Halo
    K230619 Hubly Electric Drill (H100)
    K223199 2.1 x 255mm Drill, 22mm Stop
    K213072 2.1 x 255mm Drill, 22mm Stop
    K213208 Twist Drills
    K213454 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
    K202120 P300 Attachment
    K203739 ELAN 4 Electro Motor System
    K210377 Stryker iBur hubs and cutting accessories
    K191479 Velocity Alpha Highspeed Surgical Drill System
    K183203 ELAN 4 Tools
    K183545 Anspach Helix Dissection Tools
    K191049 Stryker MIS and Footed Attachments
    K190172 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
    K182527 ELAN 4 Tools
    K172709 ELAN 4 Electro Motor System Tools
    K182436 POWEREASE System
    K170442 Cranial Drill Bits and Accessories
    K162542 OsteoMed PINNACLE Driver
    K161704 Phasor Drill
    K153519 DReal
    K143399 Stryker Footed Attachments and Cutting Accessories
    K143540 Stryker MIS Attachments and Cutting Accessories
    K143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
    K130755 HICUT HIGHSPEED INSTRUMENT
    K132436 VARIOGUIDE DRILL KIT
    K123270 POWEREASE SYSTEM
    K121264 TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
    K113476 ANSPACH DISSECTION TOOLS
    K111520 IPC POWEREASE SYSTEM
    K081475 ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
    K080802 EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
    K072315 MIDAS REX CURVED BUR
    K070876 STRYKER TWIST DRILLS
    K062842 TWIST DRILL
    K050628 ANSPACH COUPLER
    K042783 ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
    K040076 ANSPACH ADVANCED MICRO SAW ATTACHMENTS
    K032303 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
    K030172 SMALL HIGH SPEED MOTOR DRILL SYSTEM
    K022942 CRANIOCUT
    K014060 MICROAIRE 1000E SYSTEM
    K002903 ANSPACH ANGLED MICRONOSE ATTACHMENT
    K984035 XK-95 HIGH SPEED MOTOR DRILL SYSTEM
    K943541 75K STAIGHT DRILL
    K935861 MEDNEXT BUR
    K930229 CLINICAL NEURO SYSTEMS CRANIAL DRILL
    K922299 ZEPPELIN MOTOR DRILL SYSTEM
    K911819 ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
    K911812 ACRA-CUT WIRE PASS DRILL
    K905097 MICRO-AIRE MODEL NUMBER: MK-426
    K902703 CRANIOTOME BLADE OR DRILL BIT
    K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
    K900388 MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
    K881418 CRANIOTOME BLADE OR NEURO BLADE
    K880601 WIRE PASS DRILL BITS
    K875224 HUDSON CRANINAL BURRS
    K873692 RAYLOR(TM) DRILL STOP

    FEI Numbers

    This FDA classification entry is associated with 136 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 136 registration numbers. Click on an entry to view related FDA registrations.