Cleared Traditional

K843778 - MAYO ELBOW II (FDA 510(k) Clearance)

K843778 · Zimmer, Inc. · Orthopedic device
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Mar 1985
Decision
161d
Days
-
Risk

K843778 is an FDA 510(k) clearance for the MAYO ELBOW II.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 161 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 Zimmer, Inc. devices

Submission Details

510(k) Number K843778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date March 05, 1985
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -