Cleared Traditional

CUSTOM CRANIOFACIAL IMPLANT (CCI)

K121755 · Kelyniam Global, Inc. · Neurology
Sep 2012
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K121755 is an FDA 510(k) clearance for the CUSTOM CRANIOFACIAL IMPLANT (CCI), a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Kelyniam Global, Inc. (Canton, US). The FDA issued a Cleared decision on September 25, 2012, 102 days after receiving the submission on June 15, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K121755 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2012
Decision Date September 25, 2012
Days to Decision 102 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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