Cleared Special

MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM

K982154 · Danek Medical, Inc. · Orthopedic
Jul 1998
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K982154 is an FDA 510(k) clearance for the MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on July 13, 1998, 24 days after receiving the submission on June 19, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K982154 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1998
Decision Date July 13, 1998
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNI — Orthosis, Spinal Pedicle Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070

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