FDA.reportPublic FDA data

NA

Primary DI
23596010081760
Brand
NA
Company
Smith & Nephew, Inc.
Model
127860
Catalog number
127860
Device description
K-WIRE THREADED DIAMOND POINT ROUND END .062 X 9
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPIN, FIXATION, THREADED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010081760PackageGS16In Commercial Distribution
03596010081766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601008176023596010081760
03596010081766035960100817663596010081766

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

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Primary DI, Brand, Company table
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00810184540052Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
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00810184540076Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
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00810184540304Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
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00810184540359Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540366Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540373Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540380Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540397Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
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08033201841716ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841723ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841754ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841761ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
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