FDA.reportPublic FDA data

External Fixator Self-drilling self-tapping pin 3x

Primary DI
07640136270347
Brand
External Fixator Self-drilling self-tapping pin 3x
Company
GEXFIX SA
Model
2010-1020
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
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

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
07640136270347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640136270347076401362703477640136270347

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640136270002External Fixator Connection 15/151010-10002016-09-30
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

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