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Instrument Kit: Fractured Abutment/ Screw USA
FDA UDIEUDAMEDClass III (US FDA UDI)
by Integrum AB
Identity
- Trade Name
- Instrument Kit: Fractured Abutment/ Screw USA FDA UDI
- Generic Name
- Internal-external leg prosthesis osseointegration bar FDA UDI
- Device Name
- The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw. T-Handle 5mm Socket M9 Guide Pin Rescue Drill Bit Holder Drill / Torx Guide Allen Key 2.5 mm FDA UDI
- Model / Reference
- 2533 FDA UDI
- Description
- The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw. T-Handle 5mm Socket M9 Guide Pin Rescue Drill Bit Holder Drill / Torx Guide Allen Key 2.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340152102027 FDA UDI
- PMA Number
- P190009 FDA UDI
- FDA Product Code
- PJY FDA UDI
- GMDN Term
- Internal-external leg prosthesis osseointegration bar FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Internal-external leg prosthesis osseointegration bar
Instrument Kit: Fractured Abutment/ Screw USA by Integrum AB — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Internal-external leg prosthesis osseointegration bar.
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
- OPRA Implant System — Integrum AB · Class III
Cleared under the same submission
P190009 also covers:
- Fixture Removal Guide Pins Kit Platform G — Integrum AB
- Instrument Kit Marrow Blood Sample — Integrum AB
- Instrument Kit: Abutment Extraction PF G USA — Integrum AB
- Instrument Kit: Abutment Installation G USA — Integrum AB
- Instrument Kit: Fixture Removal PF G USA — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
- OPRA Implant System — Integrum AB
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Integrum AB
Sources (2)
- FDA UDI 5727fd84-2f91-43b6-80f4-62dc93f8aa77 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026