Cleared Traditional

HOWMEDICA SCN NAIL

K981261 · Howmedica Corp. · Orthopedic
Jun 1998
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K981261 is an FDA 510(k) clearance for the HOWMEDICA SCN NAIL, 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 June 22, 1998, 76 days after receiving the submission on April 7, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K981261 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1998
Decision Date June 22, 1998
Days to Decision 76 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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