PMA P960047S003

Device: HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
Applicant: Howmedica Osteonics Corp.
PMA number: P960047
Supplement: S003
Decision date: 2001-07-25
Approval order statement: APPROVAL FOR 1) A DESIGN CHANGE TO THE OUTER BEARING INSERT OF THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT - LATERALIZING THE HEAD CENTER BY 4 MM; 2) THE ADDITION OF ALUMINA FEMORAL HEADS FOR USE WITH THE HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT AND THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT.

Current openFDA PMA Record#

Device: HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT & TRIDENT CONSTRAINED ACETABULAR INSERT
Applicant: Howmedica Osteonics Corp.
PMA number: P960047
Supplement: S003
Decision date: 2001-07-25
Decision code: APPR
Date received: 2001-06-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) A DESIGN CHANGE TO THE OUTER BEARING INSERT OF THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT - LATERALIZING THE HEAD CENTER BY 4 MM; 2) THE ADDITION OF ALUMINA FEMORAL HEADS FOR USE WITH THE HOWMEDICA OSTEONICS CONSTRAINED ACETABULAR INSERT AND THE TRIDENT(R) CONSTRAINED ACETABULAR INSERT.