Cleared Traditional

K991267 - SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A

K991267 is an FDA 510(k) clearance for SPINE APPLICATIONS FOR THE MAYFIELD/ACC..., manufactured by Ohio Medical Instrument Co., Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991267 · Ohio Medical Instrument Co., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
90d
Days
Class 2
Risk

K991267 is an FDA 510(k) clearance for the SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS S.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ohio Medical Instrument Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 12, 1999 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 882.4560 - 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: 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 Ohio Medical Instrument Co., Inc. devices

FDA 510(k) Submission Details - K991267

510(k) Number K991267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date July 12, 1999
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 273
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K991267.
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · Image-Guided Neurologics, Inc. · Aug 1999
REMOTE INTRODUCER, MODEL PI-1000
K990907 · Image-Guided Neurologics, Inc. · Aug 1999
ELEKTA STEREOTACTIC GUIDE
K991636 · Elekta Instrument AB · Jul 1999
VIEWPOINT TOOLS- STERRAD
K983764 · Philips Medical Systems (Cleveland), Inc. · Jul 1999
VECTORVISION2
K983831 · Brainlab AG · May 1999
OPTICAL TRACKING SYSTEM (OTS)
K990632 · Radionics, Inc. · Apr 1999