Cleared Traditional

K053623 - NFIX FUSION SYSTEM

K053623 is an FDA 510(k) clearance for NFIX FUSION SYSTEM, manufactured by N-Spine, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K053623 · N-Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
196d
Days
Class 2
Risk

K053623 is an FDA 510(k) clearance for the NFIX FUSION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by N-Spine, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all N-Spine, Inc. devices

FDA 510(k) Submission Details - K053623

510(k) Number K053623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2005
Decision Date July 12, 2006
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 206
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K053623.
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441 · Ebi, L.P. · Jul 2006
CD HORIZON SPINAL SYSTEM
K061915 · Medtronic Sofamor Danek · Jul 2006
NUVASIVE SPHERX II SYSTEM
K061778 · Nuvasive, Inc. · Jul 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321 · Alphatec Spine, Inc. · Jul 2006
4CIS VANE SPINE SYSTEM
K060702 · Solco Biomedical Co., Ltd. · Jun 2006
NUVASIVE SPHERX SYSTEM
K060225 · Nuvasive, Inc. · Apr 2006