Cleared Traditional

K993990 - LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM

K993990 is the FDA 510(k) clearance for LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM by Stryker Instruments. It is a Class 2 Neurology device (product code GXN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993990 · Stryker Instruments · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
90d
Days
Class 2
Risk

K993990 is an FDA 510(k) clearance for the LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on February 22, 2000 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 882.5330 - 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 Stryker Instruments devices

Submission Details

510(k) Number K993990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date February 22, 2000
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.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 33
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K993990.
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc. · May 2003
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
K030378 · Stryker Instruments · Mar 2003
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · Synthes (Usa) · Jul 1999
RAPIDFLAP CRANIAL CLAMP
K991029 · Walter Lorenz Surgical, Inc. · Apr 1999