DEVICE: M.U.S.T. Monoaxial Pedicle Screw (07630030837388)

Device Identifier (DI) Information

M.U.S.T. Monoaxial Pedicle Screw
03.52.212
In Commercial Distribution

Medacta International SA
07630030837388
GS1

1
488227125 *Terms of Use
Monoax. Cannul. screw 6x45mm + Nut (1x) - Sterile
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Device Characteristics

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

GMDN

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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?
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
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FDA Product Code

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Product Code Product Code Name
MNI Orthosis, Spinal Pedicle Fixation
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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K132878 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6ec4fdf7-a3dd-4018-a30f-e8e9e01db9bc
July 06, 2018
4
September 17, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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