Cleared Traditional

K000594 - LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

K000594 is an FDA 510(k) clearance for LOCKING SCREW MANDIBULAR RECONSTRUCTION..., manufactured by Stryker Leibinger. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K000594 · Stryker Leibinger · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
290d
Days
Class 2
Risk

K000594 is an FDA 510(k) clearance for the LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Leibinger (Kalamazoo, US). The FDA issued a Cleared decision on December 8, 2000 after a review of 290 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Leibinger devices

FDA 510(k) Submission Details - K000594

510(k) Number K000594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date December 08, 2000
Days to Decision 290 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 127d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 241
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K000594.
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
K003756 · Bionx Implants, Inc. · Jan 2001
LEIBINGER NEURO CLIP SYSTEM
K003660 · Stryker Instruments · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
NEWGEN SYSTEM
K002619 · Stryker Instruments · Nov 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · Macropore Biosurgery, Inc. · Oct 2000