Cleared Traditional

K031595 - U & I AMERICA SPINAL HOOK SYSTEM

K031595 is an FDA 510(k) clearance for U & I AMERICA SPINAL HOOK SYSTEM, manufactured by U&I Corp., America. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K031595 · U&I Corp., America · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
34d
Days
Class 2
Risk

K031595 is an FDA 510(k) clearance for the U & I AMERICA SPINAL HOOK SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by U&I Corp., America (Murray, US). The FDA issued a Cleared decision on June 24, 2003 after a review of 34 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 U&I Corp., America devices

FDA 510(k) Submission Details - K031595

510(k) Number K031595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date June 24, 2003
Days to Decision 34 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 122d · This submission: 34d
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 367
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K031595.
MODIFICATION ORIA SPINAL SYSTEM
K023884 · Ortho Tec, LLC · Aug 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · Howmedica Osteonics Corp. · Jul 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · Medtronic Sofamor Danek, Inc. · Jun 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · Ortho Tec, LLC · Jun 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · Medtronic Sofamor Danek, Inc. · Jun 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · Blackstone Medical, Inc. · Jun 2003