FDA.reportPublic FDA data

SixFix Circular Fixation System

Primary DI
00855967006509
Brand
SixFix Circular Fixation System
Company
ARROWHEAD DE LLC
Model
1
Catalog number
71-10135
Device description
Full Ring, 135mm
Published
2020-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K190069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190069000SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC2019-05-14KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855967006509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855967006509008559670065098559670065090855967006509

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
901-853-4366INFO@ArrowheadDevices.com

Regulatory Flags#

DUNS number
054367577
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855967006004ARROW-LOK121-3535132016-03-23
00855967006011ARROW-LOK121-3535162016-03-23
00855967006028ARROW-LOK127-2535192016-03-23
00855967006035ARROW-LOK121-2535192016-03-23
00855967006042ARROW-LOK121-2535222016-03-23
00855967006059ARROW-LOK121-2535252016-03-23
00855967006066ARROW-LOK121-2535282017-02-18
00855967006073ARROW-LOK121-2535302016-03-23
00855967006080ARROW-LOK121-2535332016-03-23
00855967006097ARROW-LOK121-2535352016-03-23
00855967006110ARROW-LOK121-2535402016-03-23
00855967006127ARROW-LOK121-2535452016-03-23
00855967006134ARROW-LOK121-2535502016-03-23
00855967006141ARROW-LOK127-2535222016-03-23
00855967006158ARROW-LOK127-2535252016-03-23
00855967006165ARROW-LOK127-2535282016-03-23
00855967006172ARROW-LOK127-2535302016-03-23
00855967006189ARROW-LOK127-2535332016-03-23
00855967006196ARROW-LOK127-2535352016-03-23
00855967006394AMDT Mini-Rail1M7322018-09-10

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