Cleared Traditional

K033413 - SPINEASSIST DEVICE

K033413 is an FDA 510(k) clearance for SPINEASSIST DEVICE, manufactured by Mazor Surgical Technologies , Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K033413 · Mazor Surgical Technologies , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
72d
Days
Class 2
Risk

K033413 is an FDA 510(k) clearance for the SPINEASSIST DEVICE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Mazor Surgical Technologies , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on January 7, 2004 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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.

FDA 510(k) Submission Details - K033413

510(k) Number K033413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date January 07, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 149d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 408
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K033413.
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · Zimmer, Inc. · Feb 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · Elekta Instrument AB · Feb 2004
NDI PASSIVE SPHERES
K033621 · Northern Digital, Inc. · Jan 2004
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
K032917 · Orthosoft, Inc. · Oct 2003
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · Ebi, L.P. · Oct 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · Biomet, Inc. · Sep 2003
K033413 · SPINEASSIST DEVICE
Download PDF FDA Summary Mazor Surgical Techno…