Cleared Traditional

K830360 - 3M OSTEOTOMY GUIDE

K830360 is an FDA 510(k) clearance for 3M OSTEOTOMY GUIDE, manufactured by 3M Company. The device is a Class 1 Orthopedic device with product code HWT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K830360 · 3M Company · Orthopedic device
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Mar 1983
Decision
26d
Days
Class 1
Risk

K830360 is an FDA 510(k) clearance for the 3M OSTEOTOMY GUIDE. Classified as Template (product code HWT), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4800 - 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 3M Company devices

FDA 510(k) Submission Details - K830360

510(k) Number K830360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1983
Decision Date March 01, 1983
Days to Decision 26 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

HWT Device Classification - Class 1, General Controls

Product Code HWT Template
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4800
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.