Search Results
Found 1 results
510(k) Data Aggregation
K Number
K110684Device Name
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
Manufacturer
VANDUZEN DBA MEDCAD
Date Cleared
2011-06-24
(105 days)
Product Code
GXN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
VANDUZEN DBA MEDCAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.
Device Description
The MedCAD AccuShape™ PEEK Patient Specific Cranial Implant devices are individually sized and shaped implantable prosthetic cranioplasty plates intended to correct defects / replace voids in the cranial skeleton of a specific patient. The implants are designed using the patient's CT imaging data and precision manufactured from implantable grade polyether-ether-ketone (PEEK) material. The devices have a nominal thickness of 3mm, ranging from 2-5mm depending on the anatomical location. The device can be supplied as one or as multiple parts due to material constraints and/or the complexity of the device, with each part ranging in size from 10 x 10 (mm) to 200 x 200 (mm). The implants are provided with 2mm drainage holes spaced 10 mm apart from center to center with an edge margin of 10 mm. The devices are non-pyrogenic and are provided non-sterile for sterilization by the physician prior to implantation. The implants are attached to the native bone with commercially available cranioplasty fasteners.
Ask a Question
Page 1 of 1