FDA · official record K192655Substantially Equivalent

Depuy Synthes Maxillofacial Portfolio - MR Conditional

Name: Depuy Synthes Maxillofacial Portfolio - MR Conditional — FDA K192655
Creator: Synthes (USA) Products, LLC
Keywords: Depuy Synthes Maxillofacial Portfolio - MR Conditional, Depuy Synthes Maxillofacial Portfolio - MR Conditional, K192655, JEY, FDA

United StatesJEYSynthes (USA) Products, LLC

Verified

Official record identity

FDA application number: K192655
Decision date: December 30, 2019
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Synthes (USA) Products, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-09-25
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.