Cleared Traditional

K930339 - REAMER BIT

K930339 is an FDA 510(k) clearance for REAMER BIT, manufactured by Neoligaments, Ltd.. The device is a Class 1 Orthopedic device with product code HTW cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

K930339 is an FDA 510(k) clearance for the REAMER BIT. Classified as Bit, Drill (product code HTW), Class I - General Controls.

Submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on August 6, 1993 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neoligaments, Ltd. devices

FDA 510(k) Submission Details - K930339

510(k) Number K930339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

HTW Device Classification - Class 1, General Controls

Product Code HTW Bit, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.