Cleared Traditional

K901393 - MAINZ HEAD FIXATION BY PERNECZKY

K901393 is an FDA 510(k) clearance for MAINZ HEAD FIXATION BY PERNECZKY, manufactured by Zeppelin GmbH. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K901393 · Zeppelin GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
162d
Days
Class 2
Risk

K901393 is an FDA 510(k) clearance for the MAINZ HEAD FIXATION BY PERNECZKY. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Zeppelin GmbH (West Germany, DE). The FDA issued a Cleared decision on September 4, 1990 after a review of 162 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Zeppelin GmbH devices

FDA 510(k) Submission Details - K901393

510(k) Number K901393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date September 04, 1990
Days to Decision 162 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 148d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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.