Cleared Traditional

K862755 - DUNN ANTERIOR DISTRACTION SYSTEM (FDA 510(k) Clearance)

K862755 · Osteotek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Osteotek, Inc. devices

Submission Details

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

Product Code -
Device Class -