DEVICE: M.U.S.T. Monoaxial Pedicle Screw (07630030837456)

Device Identifier (DI) Information

M.U.S.T. Monoaxial Pedicle Screw
03.52.224
In Commercial Distribution

Medacta International SA
07630030837456
GS1

1
488227125 *Terms of Use
Monoax. Cannul. screw 7x55mm + 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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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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
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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

57c574f5-076b-4ece-b3a5-b046d02eaf3f
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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