Cleared Traditional

K183430 - Modular Spinal Fixation System

K183430 is the FDA 510(k) clearance for Modular Spinal Fixation System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K183430 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
92d
Days
Class 2
Risk

K183430 is an FDA 510(k) clearance for the Modular Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on March 13, 2019 after a review of 92 days - within the typical 510(k) review window.

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 Life Spine, Inc. devices

Submission Details

510(k) Number K183430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2018
Decision Date March 13, 2019
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K183430.
Vitality® Spinal Fixation System
K183550 · Zimmer Biomet Spine, Inc. · Apr 2019
Zavation Spinal System
K190361 · Zavation Medical Products, LLC · Mar 2019
EUROPA Pedicle Screw System
K180337 · MiRus, LLC · Mar 2019
ISS-JAZZ Screw System and JAZZ CAP SP
K182771 · Implanet, S.A. · Mar 2019
NuVasive Reline System
K182974 · Nu Vasive, Incorporated · Feb 2019
Pedimax II - Pedicular Screw Spinal System
K180626 · Gm Dos Reis Industria E Comerico Ltda. · Feb 2019