FDA.reportPublic FDA data

External Fixator Self-drilling self-tapping pin 5x170

Primary DI
07640136270392
Brand
External Fixator Self-drilling self-tapping pin 5x170
Company
GEXFIX SA
Model
2020-1025
Device description
non-bioabsorbable orthopaedic bone pin intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052605000EXTERNAL FIXATIONGexfix USA, Inc.2005-11-10KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640136270392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640136270392076401362703927640136270392

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
482579716
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640136270347External Fixator Self-drilling self-tapping pin 3x702010-10202016-09-30
07640136270354External Fixator Self-drilling self-tapping pin 4x1002015-10202016-09-30
07640136270385External Fixator Self-drilling self-tapping pin 5x1402020-10202016-09-30
07640136270408External Fixator Self-drilling self-tapping pin 5x2102020-10302016-09-30
07640136270415External Fixator Self-drilling self-tapping pin 5x1102020-10352016-09-30
07640136270422External Fixator Transfixing pin 4/5x2502030-10202016-09-30
07640136270439External Fixator Transfixing pin 4/5x2002030-10252016-09-30
07640136270293External Fixator Kirschner wire Ø 1.80 x 400 mm1020-10302016-09-30
07640136270002External Fixator Connection 15/151010-10002016-09-30
07640136270019External Fixator Pin cluster clamp 15 Stainless steel hardware1010-10102016-09-30
07640136270026External Fixator Reduction sleeve 15/41010-10232016-09-30
07640136270033External Fixator Reduction sleeve 15/51010-10242016-09-30
07640136270040External Fixator Reduction sleeve 15/91010-10262016-09-30
07640136270057External Fixator Carbon tube 15x1001010-10322016-09-30
07640136270064External Fixator Carbon tube 15x1251010-10332016-09-30
07640136270071External Fixator Carbon Tube 15x1501010-10342016-09-30
07640136270088External Fixator Carbon tube 15x2001010-10352016-09-30
07640136270095External Fixator Carbon tube 15x2501010-10362016-09-30
07640136270101External Fixator Connection 9 / 91010-10402016-09-30
07640136270118External Fixator Reduction sleeve 9/31010-10522016-09-30

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