FDA · official record K170773Substantially Equivalent

Stryker Universal Mesh

Name: Stryker Universal Mesh — FDA K170773
Creator: Stryker
Keywords: Stryker Universal Mesh, Stryker Universal Mesh, K170773, JEY, FDA

United StatesJEYStryker

Verified

Official record identity

FDA application number: K170773
Decision date: November 08, 2017
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Stryker

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2017-03-14
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.