Cleared Traditional

K883183 - TRACER BONE MILL

K883183 is an FDA 510(k) clearance for TRACER BONE MILL, manufactured by De Medica Mfg., Inc.. The device is a Class 1 Orthopedic device with product code LYS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K883183 · De Medica Mfg., Inc. · Orthopedic device
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Oct 1988
Decision
76d
Days
Class 1
Risk

K883183 is an FDA 510(k) clearance for the TRACER BONE MILL. Classified as Bone Mill (product code LYS), Class I - General Controls.

Submitted by De Medica Mfg., Inc. (Santa Paula, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K883183

510(k) Number K883183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date October 12, 1988
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

LYS Device Classification - Class 1, General Controls

Product Code LYS Bone Mill
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.

K883183 · TRACER BONE MILL
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