Cleared Traditional

KSF SPINAL FIXATOR (K931488) - FDA 510(k) Clearance

K931488 · Franklin Medical USA, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
302d
Days
-
Risk

K931488 is an FDA 510(k) clearance for the KSF SPINAL FIXATOR.

Submitted by Franklin Medical USA, Inc. (Concord, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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Submission Details

510(k) Number K931488 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 25, 1993
Decision Date January 21, 1994
Days to Decision 302 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
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -