DEVICE: OPRA Implant System (07340152100665)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Leg internal-external prosthesis intrafemoral bar | A sterile rod designed to be implanted into the intramedullary canal of the residual femur after transfemoral (above-the-knee) amputation to function as a stabilizing bar for the connection of a specialized external prosthesis. It is designed to project beyond the femur but not through the skin so that a transcutaneous adaptor can be attached to the distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration), and is available in a variety of diameters and lengths. |
FDA Product Code
[?]Product Code | Product Code Name |
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PJY | Transfemoral Percutaneous Prosthetic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f61cb0f-05e9-452d-bc5a-54309cc9a53a
March 29, 2018
2
November 17, 2016
March 29, 2018
2
November 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+46317601060
info@integrum.se
info@integrum.se