FDA.report

External Fixator Connection 15/15

Primary DI
07640136270002
Brand
External Fixator Connection 15/15
Company
GEXFIX SA
Model
1010-1000
Device description
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typic
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions

SubmissionSupplement
K052605000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K052605000EXTERNAL FIXATIONGexfix USA, Inc.2005-11-10KTT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640136270002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640136270002076401362700027640136270002

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
482579716
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07640136270019External Fixator Pin cluster clamp 15 Stainless st1010-10102016-09-30
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
07640136270125External Fixator Reduction sleeve 9/41010-10532016-09-30
07640136270132External Fixator Reduction sleeve 9/51010-10542016-09-30
07640136270156External Fixator Carbon rod 9x701010-10622016-09-30
07640136270163External Fixator Carbon rod 9x901010-10632016-09-30
07640136270170External Fixator Carbon rod 9x1101010-10642016-09-30
07640136270187External Fixator Carbon rod 9x1501010-10652016-09-30
07640136270194External Fixator Carbon rod 9x2001010-10662016-09-30
07640136270200External Fixator Pin cluster clamp 9/91010-10702016-09-30
07640136270231External Fixator Lengthening / compression tube1010-10902016-09-30

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