FDA.reportPublic FDA data

Six Fix Circular Fixation System

Primary DI
00850030203953
Brand
Six Fix Circular Fixation System
Company
Amdt Holdings, Inc.
Model
1
Catalog number
643020400
Device description
Smooth Wire 2.0x400mm
Published
2023-08-04
Public version status
New
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
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
00850030203953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030203953008500302039538500302039530850030203953

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
19018534366info@amdtholdings.com

Regulatory Flags#

DUNS number
117990191
Device count
1
No natural rubber latex
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
00850030203960Six Fix Circular Fixation System16435184002023-08-04
00850030203106SixFix Circular Fixation System176-114502021-04-13
00850030203113SixFix Circular Fixation System176-101122021-04-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24
07613327079517HOFFMANNStryker GmbHKTT2018-09-24
07613327079524HOFFMANNStryker GmbHKTT2018-09-24
07613327079586HOFFMANNStryker GmbHKTT2018-09-24