Cleared Special

SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT

K041449 · Interpore Cross Intl. · Orthopedic
Jul 2004
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K041449 is an FDA 510(k) clearance for the SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT, 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 July 1, 2004, 30 days after receiving the submission on June 1, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K041449 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2004
Decision Date July 01, 2004
Days to Decision 30 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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