DEVICE: MEDPOR (07613252083979)

Device Identifier (DI) Information

MEDPOR
7542
In Commercial Distribution
7542
Stryker Leibinger GmbH & Co. KG
07613252083979
GS1

1
316153956 *Terms of Use
Mandibular Angle Ramus W/Infer. Ridge ES-5 - Right
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
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.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FWP PROSTHESIS, CHIN, INTERNAL
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K922489 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Thickness: 5.0 Millimeter
Length: 79.0 Millimeter
Height: 32.0 Millimeter
Device Size Text, specify: Thickness: 4.0 Millimeter
Width: 5.0 Millimeter
CLOSE

Device Record Status

84dd3899-a737-4cb6-bcfa-734a4162074a
October 12, 2020
4
September 24, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE