FDA.reportPublic FDA data

Tiger

Primary DI
00812926027838
Brand
Tiger
Company
Trilliant Surgical, LLC
Model
210-40-014
Device description
0.045in x 6in Marked K-Wire Standard
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121008000TRILLIANT SURGICAL K-WIRESTrilliant Surgical, Ltd.2012-06-04HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926027838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926027838008129260278388129260278380812926027838

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028391925Arsenal Foot307-27-0422022-05-02
00810028391932Arsenal Foot307-27-0442022-05-02
00810028391949Arsenal Foot307-27-0462022-05-02
00810028391956Arsenal Foot307-27-0482022-05-02
00810028391963Arsenal Foot307-27-0502022-05-02
00810028391970Arsenal Foot307-35-0552022-05-02
00810028391987Arsenal Foot307-35-0602022-05-02
00810028391994Arsenal Foot307-35-0652022-05-02
00810028392007Arsenal Foot307-35-0702022-05-02
00810028392014Arsenal Foot308-27-0422022-05-02
00810028392021Arsenal Foot308-27-0442022-05-02
00810028392038Arsenal Foot308-27-0462022-05-02
00810028392045Arsenal Foot308-27-0482022-05-02
00810028392052Arsenal Foot308-27-0502022-05-02
00810028392069Arsenal Foot308-35-0552022-05-02
00810028392076Arsenal Foot308-35-0602022-05-02
00810028392083Arsenal Foot308-35-0652022-05-02
00810028392090Arsenal Foot308-35-0702022-05-02
00810028392106Arsenal Foot303-90-0012022-05-02
00810028392113Arsenal Foot303-90-0022022-05-02

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