PMA P190009S003

Device: OPRA™ System
Applicant: Integrum AB
PMA number: P190009
Supplement: S003
Product code: PJY
Decision date: 2023-04-21
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: Approval for the use of additional instruments for use with the OPRA system (i.e., the Abutment InstallationKit, the Abutment Extraction Kit, the Fixture Removal Kit, and the Fractured Abutment/ Abutment ScrewKit).

Current openFDA PMA Record#

Device: OPRA™ System
Applicant: Integrum AB
PMA number: P190009
Supplement: S003
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2023-04-21
Decision code: APPR
Date received: 2022-09-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of additional instruments for use with the OPRA system (i.e., the Abutment InstallationKit, the Abutment Extraction Kit, the Fixture Removal Kit, and the Fractured Abutment/ Abutment ScrewKit).