Cleared Special

SPIRAL RADIUS 90-D SST SYSTEM

K012273 · United States Surgical, A Division of Tyco Healthc · Orthopedic
Aug 2001
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K012273 is an FDA 510(k) clearance for the SPIRAL RADIUS 90-D SST SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on August 15, 2001, 27 days after receiving the submission on July 19, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K012273 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2001
Decision Date August 15, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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