Cleared Traditional

K030448 - OSTEOMED 2.0 LOCKING PLATES AND SCREWS

K030448 is an FDA 510(k) clearance for OSTEOMED 2.0 LOCKING PLATES AND SCREWS, manufactured by Osteomed LP. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K030448 · Osteomed LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
87d
Days
Class 2
Risk

K030448 is an FDA 510(k) clearance for the OSTEOMED 2.0 LOCKING PLATES AND SCREWS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on May 9, 2003 after a review of 87 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 Osteomed LP devices

FDA 510(k) Submission Details - K030448

510(k) Number K030448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date May 09, 2003
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 254
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K030448.
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · Synthes (Usa) · Oct 2003
UNIVERSAL NEURO SYSTEM
K031659 · Stryker Instruments · Sep 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
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THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K031028 · Bioplate, Inc. · Apr 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · Synthes (Usa) · Apr 2003
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K030806 · Bioplate, Inc. · Apr 2003