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510(k) Data Aggregation

    K Number
    K241883
    Device Name
    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)
    Manufacturer
    pro med instruments GmbH
    Date Cleared
    2024-07-26

    (28 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    pro med instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K240319
    Device Name
    DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
    Manufacturer
    Pro Med Instruments GmbH
    Date Cleared
    2024-04-24

    (82 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pro Med Instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.
    Device Description
    The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures. The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.
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    K Number
    K203505
    Device Name
    DORO QR3 Headrest System (Aluminum)
    Manufacturer
    pro med instruments GmbH
    Date Cleared
    2021-03-29

    (119 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    pro med instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
    Device Description
    DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. Adjustable Base Unit. DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position. The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.
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    K Number
    K193438
    Device Name
    DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
    Manufacturer
    Pro Med Instruments GmbH
    Date Cleared
    2020-06-02

    (174 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pro Med Instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
    Device Description
    DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.
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    K Number
    K191740
    Device Name
    DORO LUCENT® iXI and iMRI Headrest System
    Manufacturer
    Pro Med Instruments GmbH
    Date Cleared
    2020-02-21

    (235 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pro Med Instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used. The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used. The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
    Device Description
    The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed. The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board. Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System. These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets: - . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems - 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ● - . 4003.500 DORO LUCENT® iXI Headrest System By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.
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    K Number
    K191979
    Device Name
    DORO QR3 XTom Headholder System
    Manufacturer
    Pro Med Instruments GmbH
    Date Cleared
    2019-10-22

    (90 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pro Med Instruments GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.
    Device Description
    The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.
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