Cleared Special

K030252 - ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)

K030252 is an FDA 510(k) clearance for ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAX..., manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 28-day FDA review.

K030252 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
28d
Days
Class 2
Risk

K030252 is an FDA 510(k) clearance for the ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Tec, LLC (California, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030252

510(k) Number K030252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date February 21, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 415
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K030252.
MSD CABLE REDUCTION SYSTEM
K030816 · Medtronic Sofamor Danek · Jun 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · Blackstone Medical, Inc. · Feb 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · Ortho Tec, LLC · Feb 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · Depuyacromed · Jan 2003
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · Medtronic Sofamor Danek · Dec 2002
K030252 · ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
Download PDF FDA Summary Ortho Tec, LLC