FDA · official record K122647Substantially Equivalent

SYNTHES PATIENT SPECIFIC PLATE

Name: SYNTHES PATIENT SPECIFIC PLATE — FDA K122647
Creator: Synthes, Inc.
Keywords: SYNTHES PATIENT SPECIFIC PLATE, SYNTHES PATIENT SPECIFIC PLATE, K122647, JEY, FDA

United StatesJEYSynthes, Inc.

Verified

Official record identity

FDA application number: K122647
Decision date: February 28, 2013
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Synthes, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-08-30
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.