Cleared Traditional

RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS

K893377 · Richards Medical Co., Inc. · Orthopedic
Nov 1989
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K893377 is an FDA 510(k) clearance for the RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on November 16, 1989, 199 days after receiving the submission on May 1, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K893377 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1989
Decision Date November 16, 1989
Days to Decision 199 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

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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