OPRA System
FDA premarket approval P190009/S003 · decided 2023-04-21
Approval details
- PMA number
- P190009
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPRA System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2022-09-28
- Decision date
- 2023-04-21
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- Approval for the use of additional instruments for use with the OPRA system (i.e., the Abutment InstallationKit, the Abutment Extraction Kit, the Fixture Removal Kit, and the Fractured Abutment/ Abutment ScrewKit).
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