Cleared Traditional

K132403 - ANNEXTM ADJACENT LEVEL SYSTEM

K132403 is the FDA 510(k) clearance for ANNEXTM ADJACENT LEVEL SYSTEM by Spine Wave, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K132403 · Spine Wave, Inc. · Orthopedic device
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Jan 2014
Decision
162d
Days
Class 2
Risk

K132403 is an FDA 510(k) clearance for the ANNEXTM ADJACENT LEVEL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 162 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 Spine Wave, Inc. devices

Submission Details

510(k) Number K132403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date January 10, 2014
Days to Decision 162 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K132403.
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K140948 · Spineart · May 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · Spineart · May 2013
FORTEX PEDICLE SCREW SYSTEM
K120832 · X-Spine Systems, Inc. · Oct 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012