Cleared Traditional

KELYNIAM CUSTOM SKULL IMPLANT (CSI)

K103582 · Kelyniam Global, Inc. · Neurology
Apr 2011
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K103582 is an FDA 510(k) clearance for the KELYNIAM CUSTOM SKULL IMPLANT (CSI), a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Kelyniam Global, Inc. (New Britain, US). The FDA issued a Cleared decision on April 14, 2011, 127 days after receiving the submission on December 8, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K103582 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2010
Decision Date April 14, 2011
Days to Decision 127 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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