Cleared Traditional

K061600 - ARX SPINAL SYSTEM

K061600 is the FDA 510(k) clearance for ARX SPINAL SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K061600 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
75d
Days
Class 2
Risk

K061600 is an FDA 510(k) clearance for the ARX SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on August 22, 2006 after a review of 75 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life Spine devices

Submission Details

510(k) Number K061600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date August 22, 2006
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 145
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K061600.
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853 · Stryker Spine · Oct 2006
TRIO + SPINAL SYSTEM
K062698 · Stryker Spine · Oct 2006
CD HORIZON SPINAL SYSTEM
K062606 · Medtronic Sofamor Danek · Sep 2006
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978 · Ebi, L.P. · Aug 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006