Cleared Traditional

K050669 - JEIL BONE FIXATION SYSTEM

K050669 is the FDA 510(k) clearance for JEIL BONE FIXATION SYSTEM by Jeil Medical Corporation. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K050669 · Jeil Medical Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
72d
Days
Class 2
Risk

K050669 is an FDA 510(k) clearance for the JEIL BONE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Deer Field, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 72 days - a notably fast clearance 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: 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 Jeil Medical Corporation devices

Submission Details

510(k) Number K050669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2005
Decision Date May 26, 2005
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K050669.
KLS MARTIN RIGID FIXATION - STERILE
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RESORB-X SF
K051236 · KLS-Martin L.P. · Aug 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · Synthes (Usa) · May 2005
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · Synthes (Usa) · Mar 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004