Cleared Special

K021879 - CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
(FDA 510(k) Clearance)

K021879 · Depuyacromed · Orthopedic
Jun 2002
Decision
19d
Days
Class 2
Risk

K021879 is an FDA 510(k) clearance for the CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM), a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on June 26, 2002, 19 days after receiving the submission on June 7, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K021879 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2002
Decision Date June 26, 2002
Days to Decision 19 days
Submission Type Special
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