DEVICE: Screwdriver with Torque Limiter (Torx) (07290115934465)
Device Identifier (DI) Information
Screwdriver with Torque Limiter (Torx)
86567
In Commercial Distribution
PREMIA SPINE LTD
86567
In Commercial Distribution
PREMIA SPINE LTD
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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47858 | Surgical instrument torque limiter |
A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Thoracolumbosacral Pedicle Screw System |
MNI | Orthosis, Spinal Pedicle Fixation |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
QWK | Prosthesis, Posterior Spinal Elements |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K150380 | 000 |
K170061 | 000 |
K182598 | 000 |
K231844 | 000 |
P220002 | 000 |
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
0791751d-1523-40e1-9794-8bb1622b9115
September 27, 2024
2
September 03, 2024
September 27, 2024
2
September 03, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined