Cleared Traditional

K842626 - HIP PROSTHESIS PACK (FDA 510(k) Clearance)

K842626 · Deroyal Industries, Inc. · Orthopedic device
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Oct 1984
Decision
110d
Days
-
Risk

K842626 is an FDA 510(k) clearance for the HIP PROSTHESIS PACK.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 110 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.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K842626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date October 24, 1984
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -