Cleared Traditional

OSTEOMED 2.0 LOCKING PLATES AND SCREWS (K030448) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 93
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K030448.
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
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K033160 · Synthes (Usa) · Oct 2003
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K031761 · Synthes (Usa) · Sep 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · Synthes (Usa) · Apr 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · Synthes (Usa) · Jan 2003
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · Synthes (Usa) · Nov 2002