BEUDAMED
    Product Code: GWO FDA class 2 21 CFR 882.5320

    Plate, Cranioplasty, Preformed, Alterable

    Neurology

    The Plate, Cranioplasty, Preformed, Alterable is a neurosurgical implant consisting of a preformed, alterable plate used to repair skull defects following craniotomy, trauma, or other conditions requiring cranioplasty, restoring cranial contour and protecting the underlying brain. It is an FDA Class 2 device requiring 510(k) premarket clearance, and it is designated as an implant. Regulated under 21 CFR 882.5320 with product code GWO in the Neurology specialty. This device is classified as an implant.

    View on FDA
    510(k)s
    42
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    25
    Years Active
    44

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    Basic Information

    Product Code
    GWO
    Device Class
    FDA class 2
    Regulation Number
    882.5320
    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 42 510(k) clearances via K numbers.

    K Number Device Name
    K250297 TECHFIT Patient-Specific Cranial System
    K250334 Fusion Craniofacial Implant; Fusion Skull Implant
    K231834 VSP PEEK Cranial Implant
    K212391 MCI-Neuro Fixation System
    K210360 Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
    K203055 Stryker PEEK Customized Cranial Implant Kit
    K190811 Optimus NEURO System - Sterile Kit
    K190229 Stryker PEEK Customized Cranial Implant Kit
    K182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
    K183352 Optimus Neuro System
    K182425 Universal Mesh - Sterile
    K170725 Stryker Universal Mesh
    K170368 Sterile NS System
    K161821 Stryker Universal Mesh
    K161446 Biopor Porous Polyethylene Implants
    K153248 PEEK Customized Cranial Implant
    K152076 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
    K141123 ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
    K141911 OPTIMUS NEURO SYSTEM
    K141644 INNOVASIS CRANIAL SYSTEM
    K141452 LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
    K140462 MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
    K131775 UNIVERSAL NEURO 3 SYSTEM
    K123723 SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
    K122049 NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
    K121606 RESORB-X G
    K121624 BIOMET MICROFIXATION NEURO PLATING SYSTEM
    K121153 PEEK CUSTOMIZED CRAIAL IMPLANT KIT
    K120352 STRYKER QUIKFLAP STERILE PROCEDURE PACK
    K112812 LEFORTE NEURO SYSTEM BONE PLATE
    K112557 STRYKER UNIVERSAL NEURO 3 SYSTEM
    K111176 OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
    K111065 STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
    K100205 FRONTIER DEVICES NEURO SYSTEM
    K073006 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
    K072758 SYNTHES (USA) 2.0MM TITANIUM T-PLATE
    K974206 SYNTHES CRANIAL SPRING CLIP (CSC)
    K903485 TITANIUM MESH
    K861884 NEUROSCOPE SEEG
    K861822 MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
    K812952 RION AUDIOMETER AA-68
    K812951 RION AUDIOMETER AA-67

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.