Cleared Traditional

K861183 - INTRAMEDULLARY ROD

K861183 · The Deca Co. · Orthopedic device
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Aug 1986
Decision
133d
Days
-
Risk

K861183 is an FDA 510(k) clearance for the INTRAMEDULLARY ROD.

Submitted by The Deca Co. (Costa Mesa, US). The FDA issued a Cleared decision on August 11, 1986 after a review of 133 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 - K861183

510(k) Number K861183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date August 11, 1986
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -