Cleared Traditional

K851786 - 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (FDA 510(k) Clearance)

Class I Orthopedic device.

K851786 · Artiberia · Orthopedic device
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Jul 1985
Decision
75d
Days
Class 1
Risk

K851786 is an FDA 510(k) clearance for the 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF. Classified as Instrument, Cast Application/removal, Manual (product code LGG), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5980 - 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 Artiberia devices

Submission Details

510(k) Number K851786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date July 09, 1985
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGG Instrument, Cast Application/removal, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5980
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.