Cleared Traditional

ISS INTEGRATED SPINE SYSTEM

K061524 · Ortho Development Corp. · Orthopedic
Sep 2006
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K061524 is an FDA 510(k) clearance for the ISS INTEGRATED SPINE SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on September 26, 2006, 116 days after receiving the submission on June 2, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K061524 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2006
Decision Date September 26, 2006
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

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