Cleared Traditional

K021341 - NORMED BONE TRANSPORT DISTRACTION DEVICE

K021341 is an FDA 510(k) clearance for NORMED BONE TRANSPORT DISTRACTION DEVICE, manufactured by Osteomedics, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K021341 · Osteomedics, Inc. · Dental device
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Aug 2002
Decision
94d
Days
Class 2
Risk

K021341 is an FDA 510(k) clearance for the NORMED BONE TRANSPORT DISTRACTION DEVICE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomedics, Inc. (Paramus, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 94 days - within the typical 510(k) review window.

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 Osteomedics, Inc. devices

FDA 510(k) Submission Details - K021341

510(k) Number K021341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date August 01, 2002
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
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 248
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K021341.
SYNTHES MIDFACE DISTRACTOR
K022005 · Synthes (Usa) · Sep 2002
SYNTHES CRANIOFACIAL PLATES
K021642 · Synthes (Usa) · Aug 2002
OSA RIGID INTERNAL FIXATION SYSTEM
K021618 · Osteomed Corp. · Aug 2002
STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM
K022033 · Bioplate, Inc. · Jul 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · Bioplate, Inc. · Jun 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · Synthes (Usa) · May 2002