PMA P190009S011

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S011
Product code: PJY
Decision date: 2026-04-15
Classification: Orthopedic
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Approval order statement: approval for the following changes: i) changes to the transport packaging box dimensions and configuration, ii) minor changes to the package design of the fixture components; and iii) removal of the repacking step after sterilization

Current openFDA PMA Record#

Device: OPRA Implant System
Applicant: Integrum AB
PMA number: P190009
Supplement: S011
Product code: PJY
Generic name: Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Decision date: 2026-04-15
Decision code: APPR
Date received: 2026-01-15
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for the following changes: i) changes to the transport packaging box dimensions and configuration, ii) minor changes to the package design of the fixture components; and iii) removal of the repacking step after sterilization