Cleared Traditional

PASS LP Spinal System

K142798 · Medicrea International SA · Orthopedic
Mar 2015
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K142798 is an FDA 510(k) clearance for the PASS LP Spinal System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on March 25, 2015, 177 days after receiving the submission on September 29, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K142798 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2014
Decision Date March 25, 2015
Days to Decision 177 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