Cleared Traditional

K030378 - STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

K030378 is the FDA 510(k) clearance for STRYKER LEIBINGER CRANIAL FIXATION SYSTEM by Stryker Instruments. It is a Class 2 Neurology device (product code GXN) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K030378 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
43d
Days
Class 2
Risk

K030378 is an FDA 510(k) clearance for the STRYKER LEIBINGER CRANIAL FIXATION 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 March 20, 2003 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Instruments devices

Submission Details

510(k) Number K030378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2003
Decision Date March 20, 2003
Days to Decision 43 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
105d faster than avg
Panel avg: 148d · This submission: 43d
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 K030378.
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004
SPIN DOWN RAPIDFLAP
K031034 · Walter Lorenz Surgical, Inc. · May 2003
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · Stryker Instruments · Feb 2000
SYNTHES CRANIAL FLAP TWIST CLAMP
K991860 · Synthes (Usa) · Jul 1999
SYNTHES CRANIAL FLAP TUBE CLAMP
K992000 · Synthes (Usa) · Jul 1999