DEVICE: MEDPOR (07613252083993)
Device Identifier (DI) Information
MEDPOR
7544
In Commercial Distribution
7544
Stryker Leibinger GmbH & Co. KG
7544
In Commercial Distribution
7544
Stryker Leibinger GmbH & Co. KG
Mandibular Angle Ramus W/Infer. Ridge ES-10 - Right
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 |
---|---|
Mandibular condyle prosthesis | A sterile implantable device designed to 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 almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWP | PROSTHESIS, CHIN, INTERNAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Thickness: 5.0 Millimeter |
Height: 32.0 Millimeter |
Device Size Text, specify: Thickness: 4.0 Millimeter |
Length: 79.0 Millimeter |
Device Size Text, specify: Thickness: 10.0 Millimeter |
Width: 10.0 Millimeter |
Device Record Status
4a9357d0-f52a-4114-8054-31e03476bf31
March 29, 2018
2
September 24, 2015
March 29, 2018
2
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 |
---|---|---|---|---|---|
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