Cleared Special

SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS

K030103 · Depuyacromed · Orthopedic
Feb 2003
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K030103 is an FDA 510(k) clearance for the SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on February 5, 2003, 23 days after receiving the submission on January 13, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K030103 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2003
Decision Date February 05, 2003
Days to Decision 23 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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