Cleared Traditional

REAMER BIT

K930339 · Neoligaments, Ltd. · Orthopedic
Aug 1993
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K930339 is an FDA 510(k) clearance for the REAMER BIT, a Bit, Drill (Class I — General Controls, product code HTW), submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on August 6, 1993, 193 days after receiving the submission on January 25, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K930339 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1993
Decision Date August 06, 1993
Days to Decision 193 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code HTW — Bit, Drill
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540