DEVICE: DSS Pedicle screw set, Ø6.0 x 45mm (04260148892776)
Device Identifier (DI) Information
DSS Pedicle screw set, Ø6.0 x 45mm
DPI46045
In Commercial Distribution
Paradigm Spine, LLC
DPI46045
In Commercial Distribution
Paradigm Spine, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Spinal dynamic-stabilization system | A sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion. |
FDA Product Code
[?]Product Code | Product Code Name |
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NQP | Posterior Metal/Polymer Spinal System, Fusion |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
MNI | Orthosis, Spinal Pedicle Fixation |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e46a55b9-af4b-43ba-8151-a7f0cb19d887
March 29, 2018
2
October 01, 2015
March 29, 2018
2
October 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined