DEVICE: M.U.S.T. Monoaxial Pedicle Screw (07630030837333)
Device Identifier (DI) Information
M.U.S.T. Monoaxial Pedicle Screw
03.52.202
In Commercial Distribution
Medacta International SA
03.52.202
In Commercial Distribution
Medacta International SA
Monoax. Cannul. screw 5x45mm + Nut (1x) - Sterile
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37272 | Trans-facet-screw internal spinal fixation system, sterile |
A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
KWP | Appliance, Fixation, Spinal Interlaminal |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132878 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ccc13b64-cefa-4792-9465-fd4b46df5fd2
July 06, 2018
4
September 17, 2014
July 06, 2018
4
September 17, 2014
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