BEUDAMED
    Product Code: HBB FDA class 2 21 CFR 882.4370

    Motor, Drill, Pneumatic

    Neurology

    The Pneumatic Drill Motor is a compressed-air-powered drive unit used to operate neurosurgical drill bits, burrs, and trephines during cranial bone procedures such as craniotomy or craniectomy. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBB under regulation 21 CFR 882.4370 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    27
    FEI Numbers
    46
    Registration Numbers
    46
    Unique Applicants
    19
    Years Active
    36

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    Basic Information

    Product Code
    HBB
    Device Class
    FDA class 2
    Regulation Number
    882.4370
    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 27 510(k) clearances via K numbers.

    K Number Device Name
    K253772 Velocity Alpha MR High Speed Surgical Drill System
    K172907 ELAN 4 Air Motor System
    K163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
    K150801 Stryker Maestro Air Motors
    K101168 LEGEND POWER ADAPTER MODEL: 6475000
    K093361 SYNTHES AIR PEN DRIVE (APD) SYSTEM
    K090112 MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
    K061297 ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
    K061725 STRYKER ARIA PNEUMATIC SYSTEM
    K042974 MEDICON VIPAIR HIGH SPEED SYSTEM
    K041754 STRYKER MAESTRO SYSTEM
    K040186 ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
    K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K020069 MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
    K013091 ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
    K000195 CRANIAL DRILL
    K993851 SODEM PERFORATOR DRIVE
    K994175 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
    K991625 KOMET XK-95 PERFORATOR MOTOR (MI-102)
    K983092 TRITON HUDSON CHUCK ATTACHMENT
    K980686 AESCULAP HILAN MOTOR SYSTEM
    K972289 MIDAS REX MOTOR
    K954717 SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
    K962483 MIDAS REX III MOTOR
    K960630 ANSPAHC SPEED REDUCER
    K953434 MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
    K895739 MICROMEDICS SURGICAL DRILL SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.