Cleared Traditional

K900729 - NEOSERV 824 (FDA 510(k) Clearance)

K900729 · Burdick Corp. · Orthopedic device
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Jun 1990
Decision
113d
Days
-
Risk

K900729 is an FDA 510(k) clearance for the NEOSERV 824.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 113 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.

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Submission Details

510(k) Number K900729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1990
Decision Date June 08, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCJ
Device Class -