FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867543386
Brand
Arthrex®
Company
ARTHREX, INC.
Model
76-11611S
Catalog number
76-11611S
Device description
Sixfix Strut Set SF3
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00888867543386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867543386008888675433868888675433860888867543386

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867560475Arthrex®AR-9001A-5100AR-9001A-51002026-06-11
00888867561793Arthrex®AR-9850DSAR-9850DS2026-07-17
10888867501000Arthrex®76-1023076-102302026-03-13
10888867501017Arthrex®76-1023476-102342026-03-13
10888867501031Arthrex®76-1023576-102352026-03-13
10888867501048Arthrex®76-1023676-102362026-03-13
10888867544571Arthrex®71-0000471-000042026-03-13
00888867444966Arthrex®AR-9097-02AR-9097-022025-10-24
00888867444973Arthrex®AR-9097-03AR-9097-032025-10-24
00888867444980Arthrex®AR-9097-04AR-9097-042025-10-24
00888867457782Arthrex®AR-9099-02AR-9099-022025-11-28
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867320734Arthrex®AR-8981BCTJ-CPAR-8981BCTJ-CP2021-06-24
10888867335179Arthrex®AR-18700-71AR-18700-712019-12-23
00888867038417Arthrex®AR-602-48AR-602-482018-06-02
00888867218208Arthrex®AR-1788PJ-CPAR-1788PJ-CP2019-11-15
00888867135697Arthrex®AR-9145-24NLAR-9145-24NL2017-02-15
00888867135765Arthrex®AR-9145-30NLAR-9145-30NL2017-02-15
00888867135840Arthrex®AR-9145-36NLAR-9145-36NL2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
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