Cleared Traditional

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM

K982320 · Depuy, Inc. · Orthopedic
Sep 1998
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K982320 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 14, 1998, 74 days after receiving the submission on July 2, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K982320 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1998
Decision Date September 14, 1998
Days to Decision 74 days
Submission Type Traditional
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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