Cleared Traditional

K823059 - DOSIMETRY RELEASE OF RADIATION STERIL. (FDA 510(k) Clearance)

K823059 · Biomet, Inc. · Orthopedic device
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Mar 1983
Decision
150d
Days
-
Risk

K823059 is an FDA 510(k) clearance for the DOSIMETRY RELEASE OF RADIATION STERIL..

Submitted by Biomet, Inc. (Walker, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 150 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 Biomet, Inc. devices

Submission Details

510(k) Number K823059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date March 17, 1983
Days to Decision 150 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -