DEVICE: REDUCTION BOLT, TIBIAL INSERTION GUIDE, SUPRAPATELLAR (00848665036657)
Device Identifier (DI) Information
REDUCTION BOLT, TIBIAL INSERTION GUIDE, SUPRAPATELLAR
1257-100
In Commercial Distribution
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1257-100
In Commercial Distribution
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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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47875 | Bone-nailing compression screw |
A rod-like orthopaedic surgical instrument designed to be inserted (screwed) through the insertion handle of an orthopaedic implant aiming arm to impart a force upon a proximally inserted bone nail locking screw thus creating compression on the proximal section of a fractured bone to close the fracture gap with the distal section which can then be locked into final position. It is typically made of high-grade stainless steel and has a threaded portion at the proximal end together with a head for acceptance of a screwdriver or other tool to provide the necessary rotation. It is available in a variety of lengths and is usually used when nailing the tibia or humerus. 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
fe4d996d-d254-456f-85e3-376b484d4184
March 18, 2021
1
March 10, 2021
March 18, 2021
1
March 10, 2021
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
[?]
(310) 533-9966
regaffairs@aosortho.com
regaffairs@aosortho.com