DEVICE: UNIVERSAL NEURO 3 (04546540684639)
Device Identifier (DI) Information
UNIVERSAL NEURO 3
53-00466
In Commercial Distribution
53-00466
Stryker Leibinger GmbH & Co. KG
53-00466
In Commercial Distribution
53-00466
Stryker Leibinger GmbH & Co. KG
MESH PLATE, ROUND, LARGE
Device Characteristics
MR Conditional | |
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 |
---|---|
Craniofacial fixation plate, non-bioabsorbable | A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWO | Plate, cranioplasty, preformed, alterable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112557 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Thickness: 0.4 Millimeter |
Device Size Text, specify: Diameter: 57.0 Millimeter |
Device Record Status
94506503-75b9-4f12-89aa-1752865ac642
July 06, 2018
3
October 23, 2015
July 06, 2018
3
October 23, 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 |
---|---|
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