Cleared Traditional

G4 SLEEVED NAIL

K020962 · Biomet Manufacturing, Inc. · Orthopedic
May 2002
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K020962 is an FDA 510(k) clearance for the G4 SLEEVED NAIL, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Biomet Manufacturing, Inc. (Warsaw,, US). The FDA issued a Cleared decision on May 24, 2002, 60 days after receiving the submission on March 25, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K020962 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2002
Decision Date May 24, 2002
Days to Decision 60 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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