Fixture Removal Trephine and Guide Sleeve Kit 25 mm
- Primary DI
- 07340152101792
- Brand
- Fixture Removal Trephine and Guide Sleeve Kit 25 mm
- Company
- Integrum AB
- Model
- 2549
- Device description
- The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
- Published
- 2023-07-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P190009 | 003 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07340152101792 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07340152101792 | 07340152101792 | 7340152101792 |
GMDN Terms#
| Term | Definition |
|---|---|
| Internal-external leg prosthesis osseointegration bar | A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration). |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 356739813
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 07340152100313 | OPRA Implant System | 1795 | 1795 | 2016-11-17 |
| 07340152100337 | OPRA Implant System | 1797 | 1797 | 2016-11-17 |
| 07340152100344 | OPRA Implant System | 1798 | 1798 | 2016-11-17 |
| 07340152100351 | OPRA Implant System | 1816 | 1816 | 2015-12-18 |
| 07340152100368 | OPRA Implant System | 1817 | 1817 | 2016-11-17 |
| 07340152100375 | OPRA Implant System | 1818 | 1818 | 2016-03-04 |
| 07340152100382 | OPRA Implant System | 1819 | 1819 | 2016-03-04 |
| 07340152100160 | OPRA Implant System | 1353 | 1353 | 2016-03-30 |
| 07340152101709 | Fixture Removal Trephine and Guide Sleeve Kit 18 mm | 2540 | 2023-07-28 | |
| 07340152101372 | OPRA Implant System | 1472 | 2017-08-08 | |
| 07340152101389 | OPRA Implant System | 1473 | 2017-08-08 | |
| 07340152100177 | OPRA Implant System | 1800 | 1800 | 2016-03-30 |
| 07340152100184 | OPRA Implant System | 1801 | 1801 | 2016-03-30 |
| 07340152100191 | OPRA Implant System | 1802 | 1802 | 2016-03-30 |
| 07340152100207 | OPRA Implant System | 1803 | 1803 | 2016-03-30 |
| 07340152100214 | OPRA Implant System | 1804 | 1804 | 2016-03-30 |
| 07340152100221 | OPRA Implant System | 1805 | 1805 | 2016-03-30 |
| 07340152100238 | OPRA Implant System | 1806 | 1806 | 2016-03-30 |
| 07340152100245 | OPRA Implant System | 1807 | 1807 | 2016-03-30 |
| 07340152100252 | OPRA Implant System | 1808 | 1808 | 2016-03-30 |
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|---|---|---|---|---|
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| 07340152102119 | OPRA™ Implant System Abutment 12x78 +1 | Integrum AB | PJY | 2023-12-18 |
| 07340152102126 | OPRA™ Implant System Abutment 12x78 +2 | Integrum AB | PJY | 2023-12-18 |
| 07340152102133 | OPRA™ Implant System Abutment 12x78 +3 | Integrum AB | PJY | 2023-12-18 |
| 07340152102140 | OPRA™ Implant System Abutment 12x78 +4 | Integrum AB | PJY | 2023-12-18 |
| 07340152102157 | OPRA™ Implant System Abutment 12x78 +5 | Integrum AB | PJY | 2023-12-18 |
| 07340152102164 | OPRA™ Implant System Abutment 12x78 +6 | Integrum AB | PJY | 2023-12-18 |
| 07340152102171 | OPRA™ Implant System Abutment 12x78 +7 | Integrum AB | PJY | 2023-12-18 |
| 07340152102188 | OPRA™ Implant System Abutment 12x78 +8 | Integrum AB | PJY | 2023-12-18 |
| 07340152102195 | OPRA™ Implant System Abutment 12x78 +9 | Integrum AB | PJY | 2023-12-18 |
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| 07340152101679 | Fixture Removal Trephine and Guide Sleeve Kit 16,5 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101686 | Fixture Removal Trephine and Guide Sleeve Kit 17 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101693 | Fixture Removal Trephine and Guide Sleeve Kit 17,5 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101709 | Fixture Removal Trephine and Guide Sleeve Kit 18 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101716 | Fixture Removal Trephine and Guide Sleeve Kit 18,5 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101730 | Fixture Removal Trephine and Guide Sleeve Kit 19,5 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101747 | Fixture Removal Trephine and Guide Sleeve Kit 20 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101754 | Fixture Removal Trephine and Guide Sleeve Kit 21 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101761 | Fixture Removal Trephine and Guide Sleeve Kit 22 mm | Integrum AB | PJY | 2023-07-28 |
| 07340152101778 | Fixture Removal Trephine and Guide Sleeve Kit 23 mm | Integrum AB | PJY | 2023-07-28 |
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