Cleared Traditional

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE

K121818 · Oxford Performance Materials · Neurology
Feb 2013
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K121818 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 (South Windsor, US). The FDA issued a Cleared decision on February 7, 2013, 232 days after receiving the submission on June 20, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K121818 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2012
Decision Date February 07, 2013
Days to Decision 232 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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