PMA P190009S006

Device: OPRA Implant System, Abutment component
Applicant: Integrum AB
PMA number: P190009
Supplement: S006
Product code: PJY
Decision date: 2025-11-20
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: approval of an addition of a Low Plasticity Burnishing (LPB) step in the manufacturing process of the Abutment component of the OPRA device.

Current openFDA PMA Record#

Device: OPRA Implant System, Abutment component
Applicant: Integrum AB
PMA number: P190009
Supplement: S006
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2025-11-20
Decision code: APPR
Date received: 2024-09-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of an addition of a Low Plasticity Burnishing (LPB) step in the manufacturing process of the Abutment component of the OPRA device.