Cleared Traditional

K862945 - DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES (FDA 510(k) Clearance)

K862945 · Downs Surgical , Ltd. · Orthopedic device
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Aug 1986
Decision
15d
Days
-
Risk

K862945 is an FDA 510(k) clearance for the DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES.

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on August 20, 1986 after a review of 15 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K862945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date August 20, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -