Cleared Traditional

FLAMENCO SPINAL FIXATION SYSTEM

K102853 · Ulrich GmbH & Co. KG · Orthopedic
Jan 2011
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K102853 is an FDA 510(k) clearance for the FLAMENCO SPINAL FIXATION SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Ulrich GmbH & Co. KG (St. Louis, US). The FDA issued a Cleared decision on January 25, 2011, 118 days after receiving the submission on September 29, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K102853 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2010
Decision Date January 25, 2011
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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