Cleared Traditional

OSA RIGID INTERNAL FIXATION SYSTEM

K021618 · Osteomed Corp. · Dental
Aug 2002
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K021618 is an FDA 510(k) clearance for the OSA RIGID INTERNAL FIXATION SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on August 8, 2002, 84 days after receiving the submission on May 16, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K021618 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2002
Decision Date August 08, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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