Cleared Traditional

THREADED FIXATION PIN

K982931 · Sgarlato Laboratories, Inc. · Orthopedic
Oct 1998
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K982931 is an FDA 510(k) clearance for the THREADED FIXATION PIN, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Sgarlato Laboratories, Inc. (Los Gatos, US). The FDA issued a Cleared decision on October 21, 1998, 62 days after receiving the submission on August 20, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K982931 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1998
Decision Date October 21, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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