MedCAD AccuShape Titanium Patient-Specific Cranial Implant

Plate, Cranioplasty, Preformed, Non-alterable


The following data is part of a premarket notification filed by Medcad with the FDA for Medcad Accushape Titanium Patient-specific Cranial Implant.

Pre-market Notification Details

Device IDK220357
510k NumberK220357
Device Name:MedCAD AccuShape Titanium Patient-Specific Cranial Implant
ClassificationPlate, Cranioplasty, Preformed, Non-alterable
Applicant MedCAD 501 S 2nd Ave, Suite A-1000 Dallas,  TX  75226
ContactBrian Buss
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeGXN  
CFR Regulation Number882.5330 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-08
Decision Date2022-08-26


Device IdentifiersubmissionNumberSupplement
00810007631066 K220357 000
00810007631059 K220357 000
00810007631042 K220357 000
00810007631035 K220357 000
00810007631028 K220357 000
00810007631011 K220357 000
00810007631004 K220357 000
00810007630991 K220357 000

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