Cleared Traditional

K760896 - BARRIER ORTHOPAEDIC SPLIT SHEET (FDA 510(k) Clearance)

K760896 · Surgikos, Inc. · Physical Medicine device
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Jan 1977
Decision
71d
Days
-
Risk

K760896 is an FDA 510(k) clearance for the BARRIER ORTHOPAEDIC SPLIT SHEET.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1977 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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 Surgikos, Inc. devices

Submission Details

510(k) Number K760896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1976
Decision Date January 05, 1977
Days to Decision 71 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -