BEUDAMED
    Product Code: HBL FDA class 2 21 CFR 882.4460

    Holder, Head, Neurosurgical (Skull Clamp)

    Neurology

    The Neurosurgical Head Holder (Skull Clamp) is a rigid fixation device used to immobilize the patient's head in a precise, stable position during intracranial surgical procedures, allowing the surgeon to operate without risk of inadvertent head movement. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBL under regulation 21 CFR 882.4460 in the Neurology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    50
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    22
    Years Active
    43

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    Basic Information

    Product Code
    HBL
    Device Class
    FDA class 2
    Regulation Number
    882.4460
    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 50 510(k) clearances via K numbers.

    K Number Device Name
    K250423 mb-FIX Cranial Stabilization Systems
    K241883 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)
    K240319 DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
    K203505 DORO QR3 Headrest System (Aluminum)
    K193438 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
    K191740 DORO LUCENT® iXI and iMRI Headrest System
    K191701 Arcus Head Fixation Frame
    K191979 DORO QR3 XTom Headholder System
    K163322 TZ SKULL PIN Adult
    K142238 MAYFIELD Skull Clamp
    K141950 HFD100 ROCKER ARM ACCESSORY
    K122225 STERILE RADIOLUCENT SKULL PINS
    K130389 MAYFIELD INFINITY XR2 SKULL CLAMP
    K120633 MAYFIELD SKULL CLAMP
    K113748 IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
    K103493 HEAD FIATION DEVICE (HFD 100)
    K083803 FIXIT HEADREST CLAMP SYSTEM
    K091439 HEAD FIXATION ARC AND TABLE BASE
    K090695 DINKLER SURGICAL SKULL CLAMP, MODEL 0308
    K090506 MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
    K081401 MAYFIELD MR/X-RAY SKULL CLAMP
    K073163 LIMITED ARTIFACT SKULL PIN, MODEL 0107
    K072208 MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
    K071458 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
    K063494 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
    K053045 MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
    K051440 MAYFIELD INFINITY SKULL CLAMP
    K050319 MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
    K032331 DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
    K031885 NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    K021604 MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
    K002990 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
    K002276 PSI SKULL CLAMP
    K001808 DORO HEADREST SYSTEM
    K955012 MIZUHO RADIOLUCENT HEAD FRAME
    K953124 MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
    K941558 MAYFIELD CHILD DISPOSABLE SKULL PIN
    K934289 MAYFIELD RADIOLUCENT SKULL CLAMP
    K932860 MAYFIELD ADULT DISPOSABLE SKULL PIN
    K932807 MAYFIELD* A-2000 SKULL CLAMP
    K923789 MAYFIELD ADULT DISPOSABLE SKULL PIN
    K912005 CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
    K911723 CODMAN DISPOSABLE SKULL PINS
    K913170 CODMAN SKULL CLAMP
    K911772 GARDNER PINS (ADULT & CHILD)
    K912011 CODMAN SKULL CLAMP
    K901393 MAINZ HEAD FIXATION BY PERNECZKY
    K893911 MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
    K874298 MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
    K821772 SURGITA/MIZHO MICRONEUROSURGERY HEAD FR

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.