Cleared Traditional

OsteoFab Patient Specific Cranial Device

K180064 · Oxford Performance Materials, Inc. · Neurology
Jul 2018
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K180064 is an FDA 510(k) clearance for the OsteoFab Patient Specific Cranial Device, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Oxford Performance Materials, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 27, 2018, 199 days after receiving the submission on January 9, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K180064 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2018
Decision Date July 27, 2018
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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