Cleared Traditional

K834384 - MODULAR EXTREMITY CASTING SUPPORT (FDA 510(k) Clearance)

Class I Orthopedic device.

K834384 · Buckman Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
47d
Days
Class 1
Risk

K834384 is an FDA 510(k) clearance for the MODULAR EXTREMITY CASTING SUPPORT. Classified as Instrument, Cast Application/removal, Manual (product code LGG), Class I - General Controls.

Submitted by Buckman Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 47 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K834384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date January 30, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
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.