Cleared Traditional

K032520 - ORTRAUTEK TRAUMA SYSTEM

K032520 is an FDA 510(k) clearance for ORTRAUTEK TRAUMA SYSTEM, manufactured by Tekka. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K032520 · Tekka · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
89d
Days
Class 2
Risk

K032520 is an FDA 510(k) clearance for the ORTRAUTEK TRAUMA SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Tekka (Bethesda, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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.

FDA 510(k) Submission Details - K032520

510(k) Number K032520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2003
Decision Date November 12, 2003
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 128d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 293
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K032520.
THE GNATHOMETER
K033092 · Ortho Gnathics, LLC · Apr 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · Noviace Corporation · Apr 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · Inion , Ltd. · Oct 2003
ORTRAUTEK ORTHOGNATHIC SYSTEM
K031989 · Tekka · Oct 2003
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
K033121 · Synthes (Usa) · Oct 2003
K032520 · ORTRAUTEK TRAUMA SYSTEM
Download PDF FDA Summary Tekka