Cleared Traditional

TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM (K953076) - FDA 510(k) Clearance

K953076 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
609d
Days
-
Risk

K953076 is an FDA 510(k) clearance for the TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 609 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Sofamor Danek USA,Inc. devices

Submission Details

510(k) Number K953076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date February 28, 1997
Days to Decision 609 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
487d slower than avg
Panel avg: 122d · This submission: 609d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -