Cleared Traditional

K933242 - SOFAMOR ORTHOPAEDIC INSTRUMENTS (FDA 510(k) Clearance)

Class I Orthopedic device.

K933242 · Danek Medical, Inc. · Orthopedic device
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Jan 1994
Decision
210d
Days
Class 1
Risk

K933242 is an FDA 510(k) clearance for the SOFAMOR ORTHOPAEDIC INSTRUMENTS. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Danek Medical, Inc. devices

Submission Details

510(k) Number K933242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date January 28, 1994
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXH Orthopedic Manual Surgical Instrument
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.