Cleared Special

ALTIUS OCT SYSTEM

K033961 · Interpore Cross Intl. · Orthopedic
Apr 2004
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K033961 is an FDA 510(k) clearance for the ALTIUS OCT SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on April 14, 2004, 114 days after receiving the submission on December 22, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K033961 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2003
Decision Date April 14, 2004
Days to Decision 114 days
Submission Type Special
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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