PMA N18466S023

Device: ORTHOSET BONE CEMENT
Applicant: Depuy, Inc.
PMA number: N18466
Supplement: S023
Product code: LOD
Decision date: 1998-10-21
Generic name: BONE CEMENT
Approval order statement: Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.

Current openFDA PMA Record

Device: ORTHOSET BONE CEMENT
Applicant: Depuy, Inc.
PMA number: N18466
Supplement: S023
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1998-10-21
Decision code: APPR
Date received: 1998-10-01
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.