FDA · official record K022033Substantially Equivalent

STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM

Name: STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM — FDA K022033
Creator: Bioplate, Inc.
Keywords: STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM, STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM, K022033, JEY, FDA

United StatesJEYBioplate, Inc.

Verified

Official record identity

FDA application number: K022033
Decision date: July 19, 2002
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Bioplate, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2002-06-21
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4760

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.