Cleared Traditional

K880324 - MICRO-AIRE CEMENT REMOVAL TOOLS (FDA 510(k) Clearance)

Class I Orthopedic device.

K880324 · Micro-Aire Surgical Instruments, Inc. · Orthopedic device
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Feb 1988
Decision
22d
Days
Class 1
Risk

K880324 is an FDA 510(k) clearance for the MICRO-AIRE CEMENT REMOVAL TOOLS. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Aire Surgical Instruments, Inc. devices

Submission Details

510(k) Number K880324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date February 17, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.