DEVICE: Simpex Kirschner Wire (B068KD03551)
Device Identifier (DI) Information
Simpex Kirschner Wire
KD-035-5
In Commercial Distribution
KD-035-5
SIMPEX MEDICAL, INC.
KD-035-5
In Commercial Distribution
KD-035-5
SIMPEX MEDICAL, INC.
Smooth K-Wire, Double Diamond Tip; .035" DIA x 5" LG; Material: 316L Stainless Steel
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
35685 | Orthopaedic bone wire |
A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HTY | Pin, Fixation, Smooth |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K911505 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 0.9 Millimeter |
Length: 127 Millimeter |
Device Record Status
fd0983d2-2f75-4b9a-997d-786cab82ad6f
February 19, 2024
4
September 23, 2015
February 19, 2024
4
September 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
800-851-9753
info@simpexmedical.com
info@simpexmedical.com