Cleared Traditional

4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N (K043351) - FDA 510(k) Clearance

Also marketed or referenced as:
SFCD-45-3040S OR N
K043351 · Triage Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
74d
Days
-
Risk

K043351 is an FDA 510(k) clearance for the 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Triage Medical, Inc. devices

Submission Details

510(k) Number K043351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date February 18, 2005
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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