PMA P190009S004

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S004
Product code: PJY
Decision date: 2023-12-21
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: Your supplement requested approval for material changes from Oilon to PEEK for the bending and torque punch components of Axor II, OPRA Implant System.

Current openFDA PMA Record#

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S004
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2023-12-21
Decision code: APPR
Date received: 2023-09-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Your supplement requested approval for material changes from Oilon to PEEK for the bending and torque punch components of Axor II, OPRA Implant System.