Cleared Traditional

MICROPERFORATION INSTRUMENT

K001507 · Smith & Nephew, Inc. · Orthopedic
Jun 2000
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K001507 is an FDA 510(k) clearance for the MICROPERFORATION INSTRUMENT, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on June 14, 2000, 30 days after receiving the submission on May 15, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K001507 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2000
Decision Date June 14, 2000
Days to Decision 30 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LXH — Orthopedic Manual Surgical Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540

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