Cleared Traditional

K853764 - TENDON LEADER (FDA 510(k) Clearance)

K853764 · Orthopedic Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
28d
Days
-
Risk

K853764 is an FDA 510(k) clearance for the TENDON LEADER.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on October 7, 1985 after a review of 28 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 Orthopedic Systems, Inc. devices

Submission Details

510(k) Number K853764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date October 07, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -