FDA.reportPublic FDA data

SixFix Circular Fixation System

Primary DI
00850030203113
Brand
SixFix Circular Fixation System
Company
Amdt Holdings, Inc.
Model
1
Catalog number
76-10112
Device description
Washer
Published
2021-04-13
Public version status
Update
Distribution status
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
K200123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200123000Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC2020-09-22KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030203113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030203113008500302031138500302031130850030203113

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
117990191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030203786AMDT Mini-Rail1M7322021-04-12
00850030203793AMDT Mini-Rail1M7342021-04-12
00850030203809AMDT Mini-Rail1M7382021-04-12
00850030203816AMDT Mini-Rail1M7392021-04-12
00850030203823AMDT Mini-Rail1M7452021-04-12
00850030203830AMDT Mini-Rail1M7462021-04-12
00850030203847AMDT Mini-Rail1M7472021-04-12
00850030203878AMDT Mini-Rail1M7432021-04-12
00850030203885AMDT Mini-Rail1M7442021-04-12
00850030203939Six Fix Circular Fixation System16410184002023-08-04
00850030203946Six Fix Circular Fixation System16414204502023-08-04
00850030203953Six Fix Circular Fixation System16430204002023-08-04
00850030203960Six Fix Circular Fixation System16435184002023-08-04
00850030203106SixFix Circular Fixation System176-114502021-04-13
00850030203205SixFix Circular Fixation System176-102092021-04-15
00850030203212SixFix Circular Fixation System176-102102021-04-15
00850030203229SixFix Circular Fixation System176-110852021-04-15
00850030203236SixFix Circular Fixation System176-111152021-04-15
00850030203243SixFix Circular Fixation System176-112002021-04-15
00850030203250SixFix Circular Fixation System176-113002021-04-15

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