PMA P190009S012

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S012
Product code: PJY
Decision date: 2026-02-12
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: the replacement of the current laser machine used to create the BioHelix surface with a comparable machine in the manufacturing process.

Current openFDA PMA Record#

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S012
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2026-02-12
Decision code: OK30
Date received: 2026-01-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the replacement of the current laser machine used to create the BioHelix surface with a comparable machine in the manufacturing process.