DEVICE: M.U.S.T. Polyaxial Pedicle Screw (07630030837319)
Device Identifier (DI) Information
M.U.S.T. Polyaxial Pedicle Screw
03.52.040
In Commercial Distribution
Medacta International SA
03.52.040
In Commercial Distribution
Medacta International SA
Cannul. Pedicle screw 7x90mm + 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 |
---|---|
KWP | Appliance, Fixation, Spinal Interlaminal |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121115 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
71a5ba9a-13fa-4e08-89c2-d62c23d92a84
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