BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS

    K Number: K071458 · Decision Jun 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    65
    Review Days
    19

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
    K Number
    K071458
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra LifeSciences Corporation
    Date Received
    May 25, 2007
    Decision Date
    June 13, 2007
    Product Code
    HBL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBL Holder, Head, Neurosurgical (Skull Clamp)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HBL), ordered by most recent decision date.

    mb-FIX Cranial Stabilization Systems

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO QR3 Headrest System (Aluminum)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO LUCENT® iXI and iMRI Headrest System

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Integra LifeSciences Corporation

    K Number Device Name
    K251162 CUSA® Clarity Ultrasonic Surgical Aspirator System
    K250752 AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
    K240493 CUSA® Clarity Ultrasonic Surgical Aspirator System
    K230427 CUSA Clarity Ultrasonic Surgical Aspirator System
    K221835 CUSA Clarity Ultrasonic Surgical Aspirator System
    K221763 CUSA Clarity Ultrasonic Surgical Aspirator System
    K210128 INTEGRA Wound Matrix (Macro-Channels)
    K210016 Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
    K193346 Codman Surgical Patties & Strips
    K201507 Cadence Total Ankle System
    Search all 65 clearances from Integra LifeSciences Corporation →