Cleared Traditional

K832494 - SCOLIOMETER (FDA 510(k) Clearance)

K832494 · Orthopedic Systems, Inc. · Physical Medicine device
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Aug 1983
Decision
20d
Days
-
Risk

K832494 is an FDA 510(k) clearance for the SCOLIOMETER.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 20 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 Orthopedic Systems, Inc. devices

Submission Details

510(k) Number K832494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date August 16, 1983
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -