Cleared Traditional

BWM SPINE SYSTEM

K982494 · Howmedica Corp. · Orthopedic
Sep 1998
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K982494 is an FDA 510(k) clearance for the BWM SPINE SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 8, 1998, 53 days after receiving the submission on July 17, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K982494 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1998
Decision Date September 08, 1998
Days to Decision 53 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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