Cleared Traditional

K213849 - SafeOp 2: Neural Informatix System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213849 · Alphatec Spine, Inc. · Neurology device
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Mar 2022
Decision
89d
Days
Class 2
Risk

K213849 is an FDA 510(k) clearance for the SafeOp 2: Neural Informatix System. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 9, 2022 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K213849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2021
Decision Date March 09, 2022
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 138
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K213849.
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K243495 · Natus Neurology Incorporated · Dec 2024
Delphi Stimulator
K242345 · Quantalx Neuroscience · Nov 2024
SafeOp 3: Neural Informatix Systeem
K234092 · Alphatec Spine, Inc. · Apr 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc. · Mar 2024