DEVICE: REDUCTION TOOL, TIBIAL NAIL (00848665037418)
Device Identifier (DI) Information
REDUCTION TOOL, TIBIAL NAIL
0838-100
In Commercial Distribution
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0838-100
In Commercial Distribution
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
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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47904 | Orthopaedic bone-reduction tool |
A hand-held manual surgical instrument that is fed down the intramedullary canal of a long bone (e.g., the femur) to help reposition a fracture where the two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. It is typically a short cylindrical device with a protruding pointed tip (straight or angled) and which is secured to the distal end of a long, thin, flexible rod/shaft having a handle at the proximal end. It is pressed down the intramedullary canal to the fracture site and the surgeon manipulates the alignment, reducing the bone fragments under image-intensifier control. It is made of high-grade stainless steel. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K070444 | 000 |
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
3eea5e96-1d67-42e2-9ec5-74c3174a3a74
June 24, 2020
1
June 16, 2020
June 24, 2020
1
June 16, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
3105339966
regaffairs@aosortho.com
regaffairs@aosortho.com