Cleared Special

K013444 - ISOBAR SPINAL SYSTEM

K013444 is an FDA 510(k) clearance for ISOBAR SPINAL SYSTEM, manufactured by Scien'Tx USA, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K013444 · Scien'Tx USA, Inc. · Orthopedic device
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Nov 2001
Decision
30d
Days
Class 2
Risk

K013444 is an FDA 510(k) clearance for the ISOBAR SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Scien'Tx USA, Inc. (Austin, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 30 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.

View all Scien'Tx USA, Inc. devices

FDA 510(k) Submission Details - K013444

510(k) Number K013444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2001
Decision Date November 16, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
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 204
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K013444.
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · Ebi, L.P. · Jan 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · Medtronic Sofamor Danek, Inc. · Dec 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · Howmedica Osteonics Corp. · Dec 2001
MONARCH SPINAL SYSTEMS
K013294 · Depuyacromed · Oct 2001
TIMX SPINAL SYSTEMS
K013295 · Depuyacromed · Oct 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · Depuyacromed · Oct 2001