Cleared Traditional

K130447 - SPEEDY FLAP SYSTEM

K130447 is an FDA 510(k) clearance for SPEEDY FLAP SYSTEM, manufactured by Jeil Medical Corporation. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 669-day FDA review.

K130447 · Jeil Medical Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
669d
Days
Class 2
Risk

K130447 is an FDA 510(k) clearance for the SPEEDY FLAP SYSTEM. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 22, 2014 after a review of 669 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K130447

510(k) Number K130447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2013
Decision Date December 22, 2014
Days to Decision 669 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
520d slower than avg
Panel avg: 149d · This submission: 669d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 56
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K130447.
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K160707 · Fin-Ceramica Faenza S.P.A. · Dec 2016
BioArchitects Patient Specific Cranial/Craniofacial Plate
K151692 · Bioarchitects USA, LLC · Nov 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382 · KLS-Martin L.P. · Nov 2015
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082 · Osteosymbionics, LLC · May 2014
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K121818 · Oxford Performance Materials · Feb 2013
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K121755 · Kelyniam Global, Inc. · Sep 2012
K130447 · SPEEDY FLAP SYSTEM
Download PDF FDA Summary Jeil Medical Corporat…