Cleared Special

K023994 - ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ

K023994 is an FDA 510(k) clearance for ORIA SPINAL CLIP SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 64-day FDA review.

K023994 · 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
64d
Days
Class 2
Risk

K023994 is an FDA 510(k) clearance for the ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ortho Tec, LLC (California, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K023994

510(k) Number K023994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2002
Decision Date February 05, 2003
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K023994.
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc. · Jun 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290 · Scient'X USA, Inc. · May 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · Sintea Biotech, Inc. · Dec 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · Depuyacromed · Nov 2002
K023994 · ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
Download PDF FDA Summary Ortho Tec, LLC