Cleared Traditional

K864879 - OSI PAPOOSE BOARD (FDA 510(k) Clearance)

K864879 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Jan 1987
Decision
40d
Days
-
Risk

K864879 is an FDA 510(k) clearance for the OSI PAPOOSE BOARD.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 K864879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date January 21, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 114d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -