Cleared Abbreviated

TI FENESTRATED PLATE

K031772 · Interpore Cross Intl. · Orthopedic
Sep 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K031772 is an FDA 510(k) clearance for the TI FENESTRATED PLATE, 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 September 5, 2003, 88 days after receiving the submission on June 9, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K031772 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2003
Decision Date September 05, 2003
Days to Decision 88 days
Submission Type Abbreviated
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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