DEVICE: OPRA Implant System (07340152100702)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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).
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Active | true |
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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H080004 | 000 |
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
a7c807c0-f67d-408a-9cb4-0aa902fb2316
March 05, 2020
4
November 17, 2016
March 05, 2020
4
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