FDA · official record K994060Substantially Equivalent

THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE

Name: THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE — FDA K994060
Creator: Bioplate, Inc.
Keywords: THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE, THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE, K994060, JEY, FDA

United StatesJEYBioplate, Inc.

Verified

Official record identity

FDA application number: K994060
Decision date: January 24, 2001
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: Traditional
Received date: 1999-11-30
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.