FDA UDI
In Commercial Distribution
🇺🇸 United States
Instrument Kit: Fractured Abutment/ Screw USA
DI: 07340152102027
·
Model: 2533
·
Integrum AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument Kit: Fractured Abutment/ Screw USA
- Primary DI
- 07340152102027
- Version / Model
- 2533
- Company Name
- Integrum AB
- Labeler DUNS
- 356739813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-25
- Public Version
- 1
- Public Version Date
- 2023-08-02
- Public Version Status
- New
- Public Device Record Key
- 5727fd84-2f91-43b6-80f4-62dc93f8aa77
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJY | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58743 | 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). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07340152102027 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P190009 | 003 |