Cleared Traditional

K013063 - GRIP LOCK ANCHOR, MODEL 411374

K013063 is an FDA 510(k) clearance for GRIP LOCK ANCHOR, manufactured by Medtronic Neurological. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013063 · Medtronic Neurological · Neurology device
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Dec 2001
Decision
90d
Days
Class 2
Risk

K013063 is an FDA 510(k) clearance for the GRIP LOCK ANCHOR, MODEL 411374. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Neurological (Minneapolis, US). The FDA issued a Cleared decision on December 11, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Neurological devices

FDA 510(k) Submission Details - K013063

510(k) Number K013063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2001
Decision Date December 11, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 113
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K013063.
RAPID PROGRAMMAR
K030118 · Advanced Neuromodulation Systems · Mar 2003
PAINDOC
K021518 · Advanced Neuromodulation Systems · Jun 2002
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
K013120 · Medamicus, Inc. · Jan 2002
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
K010300 · Medtronic Vascular · Aug 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
K011584 · Medtronic Vascular · Jun 2001
MEDTRONIC MODEL 7499 EXTENSION
K000445 · Medtronic Vascular · Apr 2000