Cleared Special

MODIFICATION OF TSRH SPINAL SYSTEM

K984522 · Danek Medical, Inc. · Orthopedic
Jan 1999
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K984522 is an FDA 510(k) clearance for the MODIFICATION OF TSRH SPINAL 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 January 6, 1999, 16 days after receiving the submission on December 21, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K984522 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1998
Decision Date January 06, 1999
Days to Decision 16 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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