FDA · official record K171831Substantially Equivalent

Intra-Lock Bone Fixation System

Name: Intra-Lock Bone Fixation System — FDA K171831
Creator: Intra-Lock International, Inc.
Keywords: Intra-Lock Bone Fixation System, Intra-Lock Bone Fixation System, K171831, DZL, FDA

United StatesDZLIntra-Lock International, Inc.

Verified

Official record identity

FDA application number: K171831
Decision date: October 26, 2017
Published decision: Substantially Equivalent

Classification

Product code: DZL

Published parties

Applicant: Intra-Lock International, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2017-06-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4880

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.