Cleared Traditional

INTERVERTEBRAL DISC RONGEUR (K903151) - FDA 510(k) Clearance

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

K903151 · Von Zeppelin GmbH · Neurology device
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Dec 1990
Decision
146d
Days
Class 2
Risk

K903151 is an FDA 510(k) clearance for the INTERVERTEBRAL DISC RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Von Zeppelin GmbH (Pullach, DE). The FDA issued a Cleared decision on December 11, 1990 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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 Von Zeppelin GmbH devices

Submission Details

510(k) Number K903151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date December 11, 1990
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 148d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 - HAE Rongeur, Manual

All 35
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