Product code PJY
- Device name
- Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P190009S011 | OPRA Implant System | Integrum AB | 2026-04-15 |
| P190009S010 | OPRA Implant System | Integrum AB | 2026-03-12 |
| P190009S012 | OPRA Implant System | Integrum AB | 2026-02-12 |
| P190009S006 | OPRA Implant System, Abutment component | Integrum AB | 2025-11-20 |
| P190009S009 | OPRA™ Implant System | Integrum AB | 2025-08-14 |
| P190009S007 | OPRA™ Implant System | Integrum AB | 2025-01-15 |
| P190009S005 | OPRA Implant System | Integrum AB | 2024-04-09 |
| P190009S004 | OPRA Implant System | Integrum AB | 2023-12-21 |
| P190009S003 | OPRA™ System | Integrum AB | 2023-04-21 |
| P190009S002 | OPRA System | Integrum AB | 2021-02-12 |
| P190009S001 | OPRA Implant System | Integrum AB | 2021-02-12 |
| P190009 | OPRA Implant System | Integrum AB | 2020-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07340152102379 | Instrument Kit: Hammer System F/ G | Integrum AB | 2024-10-15 |
| 07340152102386 | Instrument Kit: Abutment Screw Adjustment G | Integrum AB | 2024-10-15 |
| 07340152102065 | Instrument Kit Marrow Blood Sample | Integrum AB | 2023-12-18 |
| 07340152102119 | OPRA™ Implant System Abutment 12x78 +1 | Integrum AB | 2023-12-18 |
| 07340152102126 | OPRA™ Implant System Abutment 12x78 +2 | Integrum AB | 2023-12-18 |
| 07340152102133 | OPRA™ Implant System Abutment 12x78 +3 | Integrum AB | 2023-12-18 |
| 07340152102140 | OPRA™ Implant System Abutment 12x78 +4 | Integrum AB | 2023-12-18 |
| 07340152102157 | OPRA™ Implant System Abutment 12x78 +5 | Integrum AB | 2023-12-18 |
| 07340152102164 | OPRA™ Implant System Abutment 12x78 +6 | Integrum AB | 2023-12-18 |
| 07340152102171 | OPRA™ Implant System Abutment 12x78 +7 | Integrum AB | 2023-12-18 |
| 07340152102188 | OPRA™ Implant System Abutment 12x78 +8 | Integrum AB | 2023-12-18 |
| 07340152102195 | OPRA™ Implant System Abutment 12x78 +9 | Integrum AB | 2023-12-18 |
| 07340152102201 | OPRA™ Implant System Abutment 12x78 +10 | Integrum AB | 2023-12-18 |
| 07340152102218 | OPRA™ Implant System Drill-bit 11,7 mm | Integrum AB | 2023-12-18 |
| 07340152101761 | Fixture Removal Trephine and Guide Sleeve Kit 22 mm | Integrum AB | 2023-07-28 |
| 07340152101747 | Fixture Removal Trephine and Guide Sleeve Kit 20 mm | Integrum AB | 2023-07-28 |
| 07340152101754 | Fixture Removal Trephine and Guide Sleeve Kit 21 mm | Integrum AB | 2023-07-28 |
| 07340152101709 | Fixture Removal Trephine and Guide Sleeve Kit 18 mm | Integrum AB | 2023-07-28 |
| 07340152101778 | Fixture Removal Trephine and Guide Sleeve Kit 23 mm | Integrum AB | 2023-07-28 |
| 07340152101785 | Fixture Removal Trephine and Guide Sleeve Kit 24 mm | Integrum AB | 2023-07-28 |
| 07340152101792 | Fixture Removal Trephine and Guide Sleeve Kit 25 mm | Integrum AB | 2023-07-28 |
| 07340152101730 | Fixture Removal Trephine and Guide Sleeve Kit 19,5 mm | Integrum AB | 2023-07-28 |
| 07340152101716 | Fixture Removal Trephine and Guide Sleeve Kit 18,5 mm | Integrum AB | 2023-07-28 |
| 07340152101693 | Fixture Removal Trephine and Guide Sleeve Kit 17,5 mm | Integrum AB | 2023-07-28 |
| 07340152101686 | Fixture Removal Trephine and Guide Sleeve Kit 17 mm | Integrum AB | 2023-07-28 |
| 07340152101679 | Fixture Removal Trephine and Guide Sleeve Kit 16,5 mm | Integrum AB | 2023-07-28 |
| 07340152102027 | Instrument Kit: Fractured Abutment/ Screw USA | Integrum AB | 2023-07-25 |
| 07340152101662 | Fixture Removal Trephine and Guide Sleeve Kit 16 mm | Integrum AB | 2023-07-15 |
| 07340152101723 | Fixture Removal Trephine and Guide Sleeve Kit 19 mm | Integrum AB | 2023-07-15 |
| 07340152101235 | OPRA Implant System | Integrum AB | 2016-09-09 |