Cleared Traditional

K834499 - SHEATHS FOR REINFORCING BONE CEMENT (FDA 510(k) Clearance)

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.

View all Mecron Medical Products, Inc. devices

Submission Details

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
12d slower than avg
Panel avg: 114d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -