DEVICE: Remedy Spacer (00855195006500)
Device Identifier (DI) Information
Remedy Spacer
RKFMXL
In Commercial Distribution
OSTEOREMEDIES, LLC
RKFMXL
In Commercial Distribution
OSTEOREMEDIES, LLC
Remedy Femoral Component 84mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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33982 | Orthopaedic cement spacer |
A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MBB | Bone Cement, Antibiotic |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K112470 | 000 |
K183017 | 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
b97330c3-bf30-4a0f-8e38-32627204034a
November 01, 2019
4
April 10, 2017
November 01, 2019
4
April 10, 2017
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
[?]
No Customer Contact currently defined