DEVICE: NA (10849771048890)
Device Identifier (DI) Information
NA
K-Wires and Steinmann Pin
In Commercial Distribution
KI71106
KEY SURGICAL, INC.
K-Wires and Steinmann Pin
In Commercial Distribution
KI71106
KEY SURGICAL, INC.
K-Wires, Double trocar, .035-inch (0.9mm) diameter, 5-inch (12.7cm) long
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? |
---|---|---|---|---|
32854 | Orthopaedic bone pin, non-bioabsorbable |
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HTY | PIN, FIXATION, SMOOTH |
HWC | Screw, fixation, bone |
HRS | Plate, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102845 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 0.9 Millimeter |
Length: 12.7 Centimeter |
Device Record Status
57739420-898f-4508-ac24-b19dca4098b3
September 18, 2023
3
January 26, 2023
September 18, 2023
3
January 26, 2023
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:
00849771048893
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)541-7995
regulatory@keysurgical.com
regulatory@keysurgical.com