Cleared Traditional

K834499 - SHEATHS FOR REINFORCING BONE CEMENT

K834499 · Mecron Medical Products, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
126d
Days
-
Risk

K834499 is an FDA 510(k) clearance for the SHEATHS FOR REINFORCING BONE CEMENT.

Submitted by Mecron Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K834499

510(k) Number K834499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date April 24, 1984
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -