FDA · official record K952812Substantially Equivalent

3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS

Name: 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS — FDA K952812
Creator: Implant Innovations, Inc.
Keywords: 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS, 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS, K952812, JEY, FDA

United StatesJEYImplant Innovations, Inc.

Verified

Official record identity

FDA application number: K952812
Decision date: August 30, 1995
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Implant Innovations, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-06-19
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.