Cleared Traditional

OSTEOMED CRANIAL FLAP FIXATION SYSTEM

K022277 · Osteomed Corp. · Neurology
Apr 2003
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K022277 is an FDA 510(k) clearance for the OSTEOMED CRANIAL FLAP FIXATION SYSTEM, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on April 1, 2003, 260 days after receiving the submission on July 15, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K022277 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2002
Decision Date April 01, 2003
Days to Decision 260 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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