OPRA Implant System, Abutment component
FDA premarket approval P190009/S006 · decided 2025-11-20
Approval details
- PMA number
- P190009
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPRA Implant System, Abutment component
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2024-09-27
- Decision date
- 2025-11-20
- Days to decision
- 419 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- approval of an addition of a Low Plasticity Burnishing (LPB) step in the manufacturing process of the Abutment component of the OPRA device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.