Cleared Traditional

K132403 - ANNEXTM ADJACENT LEVEL SYSTEM

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

K132403 · Spine Wave, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K132403

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.

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 269
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K132403.
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · Spinefrontier, Inc. · May 2014
TRUE SPINAL FUSSION SYSTEM
K133690 · Innovative Surgical Designs · May 2014
PRESSON SPINAL FIXATION SYSTEM
K133287 · Nexus Spine, LLC · Feb 2014
PERFIX ILIAC SCREW SYSTEM
K132218 · U&I Corporation · Dec 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · U&I Corporation · Nov 2013
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
K131538 · Captiva Spine · Aug 2013