Cleared Traditional

K031576 - SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

K031576 is an FDA 510(k) clearance for SPARTAN ORTHOPAEDIC WRIST BRACE, manufactured by Surgitech, Inc.. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K031576 · Surgitech, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K031576

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.

IQI Device Classification - Class 1, General Controls

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 23
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K031576.
SENSOR WALK
K052771 · Otto Bock Healthcare LP · May 2006
ACCUFLEX DYNAMIC ELBOW ORTHOSIS
K926391 · Regulatory & Marketing Services, Inc. · Jul 1993
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
VARIOUS SUPPORTS AND SPLINTS
K823812 · Danek Medical, Inc. · Jan 1983
ROTATION BOOT
K823160 · Warm & Form, Orthopedic Materials · Nov 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982