DEVICE: Ø5.5mm x 35mm Pedicle Screw with Set Screw Package (B064XM21555351)
Device Identifier (DI) Information
Ø5.5mm x 35mm Pedicle Screw with Set Screw Package
XM-215-5535
In Commercial Distribution
XENCO MEDICAL LLC
XM-215-5535
In Commercial Distribution
XENCO MEDICAL 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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Bone rasp | A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device. |
FDA Product Code
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
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
23a39d92-90e1-4031-8fed-f1974f3c8577
March 29, 2018
2
October 29, 2015
March 29, 2018
2
October 29, 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