Cleared Traditional

KESSELL TOTAL SHOULDER (K770079) - FDA 510(k) Clearance

K770079 · Orthopedic Equipment Co., Inc. · Orthopedic device
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Jan 1977
Decision
11d
Days
-
Risk

K770079 is an FDA 510(k) clearance for the KESSELL TOTAL SHOULDER.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1977 after a review of 11 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 Equipment Co., Inc. devices

Submission Details

510(k) Number K770079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1977
Decision Date January 25, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -