FDA.reportPublic FDA data

External Fixator Trocar L = 70

Primary DI
07640136270491
Brand
External Fixator Trocar L = 70
Company
GEXFIX SA
Model
5025-1000
Device description
Reusable external orthopaedic fixation system instrument intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated, reusable device.
Published
2016-09-30
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
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
07640136270491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640136270491076401362704917640136270491

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable 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
07640136270392External Fixator Self-drilling self-tapping pin 5x1702020-10252016-09-30
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

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