DEVICE: MEDPOR (07613252086598)
Device Identifier (DI) Information
MEDPOR
9959
In Commercial Distribution
9959
Stryker Leibinger GmbH & Co. KG
9959
In Commercial Distribution
9959
Stryker Leibinger GmbH & Co. KG
Mandibular Angle RZ Large - Left 11mm L.P.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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? |
---|---|---|---|---|
35943 | Mandibular condyle prosthesis |
An implantable device designed to permanently replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is typically used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWP | PROSTHESIS, CHIN, INTERNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K922489 | 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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Length: 65.0 Millimeter |
Height: 35.0 Millimeter |
Device Size Text, specify: Thickness: 11.0 Millimeter |
Device Record Status
b484a42b-c158-4d17-a5ba-0a6fb8f6d565
June 09, 2025
5
September 24, 2015
June 09, 2025
5
September 24, 2015
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