OPRA Implant System
FDA premarket approval P190009/S004 · decided 2023-12-21
Approval details
- PMA number
- P190009
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPRA Implant System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2023-09-25
- Decision date
- 2023-12-21
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- 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.
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