Cleared Traditional

SPIRAL RADIUS 90-D RODDING SYSTEM

K020134 · United States Surgical, A Division of Tyco Healthc · Orthopedic
Apr 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K020134 is an FDA 510(k) clearance for the SPIRAL RADIUS 90-D RODDING SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 15, 2002, 90 days after receiving the submission on January 15, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K020134 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2002
Decision Date April 15, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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