FDA.reportPublic FDA data

Simpex Kirschner Wire

Primary DI
B068TK03561
Brand
Simpex Kirschner Wire
Company
SIMPEX MEDICAL, INC.
Model
TK-035-6
Catalog number
TK-035-6
Device description
"Smooth K-Wire, Double Trocar Tip; .035"" DIA x 6"" LG; Material: 316L Stainless Steel"
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911505000FIXATION WIRESimpex, Inc.1991-04-12HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B068TK03561PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length152Millimeter
Outer Diameter0.9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-851-9753info@simpexmedical.com

Regulatory Flags#

DUNS number
932637023
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B068B125121Simpex Steinmann PinB-125-12B-125-122016-09-26
B068D0781Simpex Steinmann PinD-078D-0782015-09-23
B068D078121Simpex Steinmann PinD-078-12D-078-122015-09-23
B068D07812S1Simpex Steinmann PinD-078-12SD-078-12S2015-09-23
B068D078S1Simpex Steinmann PinD-078-SD-078-S2015-09-23
B068D0931Simpex Steinmann PinD-093D-0932015-09-23
B068D093121Simpex Steinmann PinD-093-12D-093-122015-09-23
B068D09312S1Simpex Steinmann PinD-093-12SD-093-12S2015-09-23
B068D093S1Simpex Steinmann PinD-093-SD-093-S2015-09-23
B068D1091Simpex Steinmann PinD-109D-1092015-09-23
B068D109121Simpex Steinmann PinD-109-12D-109-122015-09-23
B068D10912S1Simpex Steinmann PinD-109-12SD-109-12S2015-09-23
B068D109S1Simpex Steinmann PinD-109-SD-109-S2015-09-23
B068D1251Simpex Steinmann PinD-125D-1252015-09-23
B068D125121Simpex Steinmann PinD-125-12D-125-122015-09-23
B068D12512S1Simpex Steinmann PinD-125-12SD-125-12S2015-09-23
B068D125S1Simpex Steinmann PinD-125-SD-125-S2015-09-23
B068D1401Simpex Steinmann PinD-140D-1402015-09-23
B068D140121Simpex Steinmann PinD-140-12D-140-122015-09-23
B068D14012S1Simpex Steinmann PinD-140-12SD-140-12S2015-09-23

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