Cleared Traditional

OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM

K982798 · Osteonics Corp. · Orthopedic
Mar 1999
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K982798 is an FDA 510(k) clearance for the OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Osteonics Corp. (Allendale,, US). The FDA issued a Cleared decision on March 25, 1999, 227 days after receiving the submission on August 10, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K982798 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1998
Decision Date March 25, 1999
Days to Decision 227 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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