Cleared Traditional

K880263 - OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION

K880263 is an FDA 510(k) clearance for OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code JEB cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K880263 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Mar 1988
Decision
53d
Days
Class 1
Risk

K880263 is an FDA 510(k) clearance for the OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION. Classified as Table, Surgical With Orthopedic Accessories, Manual (product code JEB), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery device framework. 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

FDA 510(k) Submission Details - K880263

510(k) Number K880263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1988
Decision Date March 15, 1988
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

JEB Device Classification - Class 1, General Controls

Product Code JEB Table, Surgical With Orthopedic Accessories, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.