Cleared Traditional

K862755 - DUNN ANTERIOR DISTRACTION SYSTEM

K862755 · Osteotek, Inc. · Orthopedic device
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Jan 1987
Decision
184d
Days
-
Risk

K862755 is an FDA 510(k) clearance for the DUNN ANTERIOR DISTRACTION SYSTEM.

Submitted by Osteotek, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 22, 1987 after a review of 184 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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.

FDA 510(k) Submission Details - K862755

510(k) Number K862755 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 22, 1986
Decision Date January 22, 1987
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 122d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -
K862755 · DUNN ANTERIOR DISTRACTION SYSTEM
Download PDF Osteotek, Inc.