Cleared Special

K022033 - STERILE PLATE & SCREW KIT CONFIGURATION...

K022033 is an FDA 510(k) clearance for STERILE PLATE & SCREW KIT CONFIGURATION..., manufactured by Bioplate, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 28-day FDA review.

K022033 · Bioplate, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
28d
Days
Class 2
Risk

K022033 is an FDA 510(k) clearance for the STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM F.... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bioplate, Inc. (Washington, US). The FDA issued a Cleared decision on July 19, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioplate, Inc. devices

FDA 510(k) Submission Details - K022033

510(k) Number K022033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date July 19, 2002
Days to Decision 28 days
Submission Type Special
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
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K022033.
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
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
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002