Cleared Traditional

ZETA MULTIZONE LOCKING NAIL SYSTEM

K982958 · Howmedica Corp. · Orthopedic
Nov 1998
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K982958 is an FDA 510(k) clearance for the ZETA MULTIZONE LOCKING NAIL SYSTEM, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 20, 1998, 88 days after receiving the submission on August 24, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K982958 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1998
Decision Date November 20, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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