Cleared Traditional

K934260 - BARRIER BONE WAX APPLICATOR (FDA 510(k) Clearance)

Class I Orthopedic device.

K934260 · Phillips Pharmaceuticals, Inc. · Orthopedic device
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Jan 1994
Decision
148d
Days
Class 1
Risk

K934260 is an FDA 510(k) clearance for the BARRIER BONE WAX APPLICATOR. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Phillips Pharmaceuticals, Inc. (Naperville, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 148 days - within the typical 510(k) review window.

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 Phillips Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K934260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date January 26, 1994
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
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.