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510(k) K100205

FRONTIER DEVICES NEURO SYSTEM by Folsom Metal Products, Inc. — Product Code GWO

K100205 is an FDA 510(k) premarket notification submitted by Folsom Metal Products, Inc. for the device "FRONTIER DEVICES NEURO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2010. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2010
Date Received
January 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

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  • K190811 — Optimus NEURO System - Sterile Kit (November 27, 2019)
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  • K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (May 21, 2019)

FDA data resources