Cleared Traditional

DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS

K982511 · Depuy, Inc. · Orthopedic
Sep 1998
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K982511 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS, 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, 56 days after receiving the submission on July 20, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K982511 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1998
Decision Date September 14, 1998
Days to Decision 56 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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