Cleared Traditional

K903151 - INTERVERTEBRAL DISC RONGEUR

K903151 is an FDA 510(k) clearance for INTERVERTEBRAL DISC RONGEUR, manufactured by Von Zeppelin GmbH. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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.

FDA 510(k) Submission Details - K903151

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 149d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K903151.
ULTRA-LINE RONGEUR
K943635 · V. Mueller Neuro/Spine · Dec 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc · Jul 1994
NEDBOND EJECTOR KERRISON RONGEUR
K933978 · Redmond Neurotechnologies Corp. · Jan 1994
SPECIAL RONGEUR
K903401 · Sur-Med Instruments, Inc. · Aug 1990
INSTRUMENTS FOR NEUROLOGICAL SURGERY
K901313 · Von Zeppelin GmbH · Jul 1990
LAMINECTOMY RONGEUR
K901372 · Zeppelin GmbH · Jun 1990
K903151 · INTERVERTEBRAL DISC RONGEUR
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