Cleared Traditional

SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) - FDA 510(k) Clearance

Class I Physical Medicine device.

K031576 · Surgitech, Inc. · Physical Medicine device
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Jul 2003
Decision
72d
Days
Class 1
Risk

K031576 is an FDA 510(k) clearance for the SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Surgitech, Inc. (Oceanside, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine 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 Surgitech, Inc. devices

Submission Details

510(k) Number K031576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date July 31, 2003
Days to Decision 72 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.

Regulatory Peers - IQI Orthosis, Limb Brace

All 51
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K031576.
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
LIMB ORTHOSIS
K810443 · Fred Sammons, Inc. · Mar 1981
BAUER & BLACK RIGID WRIST BRACE
K801701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980