Cleared Traditional

K003911 - TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)

K003911 is an FDA 510(k) clearance for TERRAY STAINLESS STEEL ROD (STRAIGHT, manufactured by Terray Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K003911 · Terray Corp. · Orthopedic device
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Mar 2001
Decision
84d
Days
Class 2
Risk

K003911 is an FDA 510(k) clearance for the TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Terray Corp. (Arnprior, CA). The FDA issued a Cleared decision on March 13, 2001 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory 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 Terray Corp. devices

FDA 510(k) Submission Details - K003911

510(k) Number K003911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date March 13, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 354
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K003911.
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ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · Ortho Tec, LLC · Mar 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc. · Jan 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · Depuyacromed · Jan 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · Depuyacromed · Dec 2000