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510(k) K220357

MedCAD AccuShape Titanium Patient-Specific Cranial Implant by Medcad — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
February 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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