Cleared Traditional

DEPUY ACROMED MOSS SPINAL SYSTEM

K984378 · Depuy, Inc. · Orthopedic
Dec 1998
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K984378 is an FDA 510(k) clearance for the DEPUY ACROMED MOSS SPINAL SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 30, 1998, 23 days after receiving the submission on December 7, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K984378 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1998
Decision Date December 30, 1998
Days to Decision 23 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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