Cleared Traditional

K864340 - WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS (FDA 510(k) Clearance)

K864340 · Buckman Co., Inc. · Orthopedic device
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Nov 1986
Decision
20d
Days
-
Risk

K864340 is an FDA 510(k) clearance for the WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 20 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K864340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date November 24, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -