Cleared Traditional

K863215 - FASCICULATED I ROD

K863215 · The Deca Co. · Orthopedic device
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Dec 1986
Decision
126d
Days
-
Risk

K863215 is an FDA 510(k) clearance for the FASCICULATED I ROD.

Submitted by The Deca Co. (Costa Mesa, US). The FDA issued a Cleared decision on December 24, 1986 after a review of 126 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K863215

510(k) Number K863215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1986
Decision Date December 24, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -